bluuebunny/crossref_metadata_2025 huggingface dataset:
P195 Prevalence and factors associated with fatigue in patients with inflammatory bowel disease
Authors: Kallel H , Elleuch N , Limam R , Dahmeni W , Hammami A , Braham A , Ben Slama A , Jaziri H , Ksiaa M
Published: January 2024

Background

Inflammatory bowel disease (IBD) is a group of pathologies characterized by symptoms that can be distressing and incapacitating. Fatigue is one of the complaints most frequently reported by patients. However, few studies have analyzed the determinants of fatigue in IBD. The aim of our work is to estimate the prevalence of fatigue, and to identify the factors associated with it in IBD patients.

Methods

Fatigue and nine other dimensions of IBD-related disability were assessed in a cross-sectional survey, including patients followed and hospitalized between March and September 2023, using the IBD-Disk questionnaire. Fatigue and severe fatigue were defined by an "Energy" sub-score > 5 and > 7 respectively. The correlation between Energy and the other IBD-Disk items was analyzed using Pearson's correlation coefficient. Determinants of fatigue were assessed using the Chi-2 test and multinomial logistic regression.

Results

We included 166 patients, 53.6% were men, and 69.3% were Crohn's disease carriers. Mean age was 39 ± 12.7 years. More than two-thirds (69.9%) lived in urban areas. IBD was active in 48.8% of cases. A total of 59% of patients were on biotherapy for maintenance treatment. The mean IBD-Disk total score was 36.4 ± 21. The Energy subscore obtained the highest score (4.9 ± 2.9). The prevalence rates for fatigue and severe fatigue were 42.2% and 22.9% respectively. Significant correlations were observed between fatigue and all other dimensions of IBD-related disability assessed by the IBD-Disk (p<0.001). The strongest correlations were observed between fatigue and defecation regulation (r=0.642), fatigue and work and study (r=0.630), and between fatigue and sleep (r=0.620) (Table 1). In univariate analysis, factors significantly associated with fatigue and severe fatigue were female gender (p=0.040 and 0.047 respectively), disease activity and hospitalization (p<0, 001 each), anemia (p=0.005 and 0.014 respectively), elevated CRP (p<0.001 and 0.030 respectively), hypoalbuminemia (p<0.001 and 0.042 respectively) and absence of biotherapy treatment (p=0.02 and 0.01 respectively). Living in an urban area was also associated with fatigue (p=0.015). In multivariate analysis, the independent risk factors predictive of fatigue were female gender, urban origin, hospitalization at the time of interview, and clinical disease activity. Independent risk factors for severe fatigue in multivariate analysis were female gender and clinical disease activity (Table 2).

Conclusion

The causes of fatigue are multiple and go beyond the clinico-biological elements associated with IBD, also encompassing social, geographical and sleep disturbance aspects. This underlines the need for a holistic approach to the management of IBD patients.
P200 Oral Mannitol for bowel preparation in IBD patients: a post-hoc analysis of a multicentre, controlled, randomized clinical trial
Authors: Tontini G E , Rimondi A , Caprioli F , Radaelli F , Spada C , Vecchi M
Published: January 2024

Background

Bowel preparation is the most burdensome part of the whole colonoscopy procedure according to patients. A diagnosis of Inflammatory Bowel Disease (IBD) implies the need for lifelong repeated colonoscopies, therefore amplifying the problem. Bowel preparation with oral Mannitol, a sugar alcohol with a sweet taste, could significantly improve the patients’ tolerance as it has a quick onset, is single dose and has a low volume.1-3

Methods

This is a post-hoc analysis of IBD patients included in the SATISFACTION study, a third phase multicentre, international, randomized, endoscopists-blinded controlled trial4. Patients were randomized (1:1) to 750mL of oral mannitol (OM, 100 g in 750 mL water) to be drunk in a single dose 4 hours before colonoscopy versus a standard split preparation with 2L PEG-ASC (PEG). An intention to treat analysis was performed on patients who underwent colonoscopy and who took bowel preparation even partially. Biological important parameters summarising the rate of bowel cleansing and patients’ satisfaction were collected.

Results

A total of 55 IBD patients (M = 24, P = 31, Crohn’s = 12, Ulcerative Colitis = 40, Microscopic colitis =3) from 7 centres were ruled in for this post-hoc analysis. The two population were comparable in terms of age and sex and diseases (Table 1). A statistically significant preference of OMl over PEG was found in terms of taste (numerical rating scale – NRS, p < 0.001), willingness to reuse the preparation (p = 0.03), and of time of first evacuation (M 56.6 minutes, P 90.7, p = 0.01). No differences were found in terms of adequate bowel cleansing as assessed by the Boston bowel preparation scale (96% OM, 97% PEG), adherence to bowel preparation (complete in 100% OM, 94% PEG) and easy of use (88% OM, 71% PEG). Minor and expected adverse events of special interest such as nausea and abdominal pain were comparable in the two courts (12% OM, 3% PEG).

Conclusion

Bowel preparation with a very low volume of oral mannitol in a single dose 4 h before colonoscopy provides better satisfaction among IBD patients and showed an excellent efficacy and safety profile as compared to the standard split preparation with 2L PEG-ASC. Same day bowel preparation with oral mannitol is a reliable option for colonoscopy in IBD and an effective strategy to improve the patients’ acceptance.

Funding/Acknowledgment

The Satisfaction study was funded by NTC, Milan, Italy.

References

1. Spada C et al. Eur J Clin Pharmacol. 2022 Dec;78(12):1991-2002.

2. Fiori G et al. Clin Transl Sci. 2022 Oct;15(10):2448-2457.

3. Carnovali M et al. Clin Transl Sci. 2023 May;16(5):759-769.

4. Tontini G.E. et al. Endoscopy 2023; 55; s64
P213 ArgesMES: A high-performance, generalizable AI model for scoring Ulcerative Colitis severity from endoscopy videos
Authors: Chaitanya K , Zemlianskaia N , Damasceno P , Scherer E , Ulloa Cerna A , Mobadersany P , Parmar C , Surace L , Yarani S , Huang K H G , Germinaro M , Kwon J , Ghanem L R , Mansi T , Oana Cula G , Standish K
Published: January 2024

Background

The Mayo endoscopic subscore (MES) is widely used to assess endoscopic disease severity assigned by human readers in Ulcerative Colitis (UC) clinical trials. AI-based automation of the MES could reduce inter-rater variability and allow for the development of more sensitive endoscopic measures. This report assesses whether a previously trained (locked) algorithm is suitable for automating full colon or segment-level MES scoring on a prospective UC clinical trial.

Methods

Endoscopy videos from two UC clinical trials (UNIFI: NCT02407236, Phase 3, 965 subjects, 3128 videos; and JAK-UC: NCT01959282, Phase 2, 211 subjects, 448 videos) were used to train an AI-based MES classifier, where 20% of the total data was retained as a holdout set. This AI model training had two steps: 1) training a feature extraction module using self-supervised learning (SSL), and 2) supervised training of a small transformer network with an attention-based classifier using SSL features to estimate full colon MES. Videos from an independent, prospective UC trial (QUASAR: NCT04033445, Phase 2b induction study, 313 subjects, 615 videos) were used to validate the locked AI model. MES scoring in QUASAR included full colon MES values and additional MES values for three left colon segments: descending colon, sigmoid colon, and rectum. Comparisons between AI-model and human reader scores were performed using AUC, Accuracy, F1 score, and Fleiss kappa. A non-inferiority test was also conducted to determine interchangeability between AI- and human-derived full colon MES values.

Results

Full colon MES on the QUASAR data showed AUC, Accuracy, and F1 scores of 0.810, 0.687, and 0.693, respectively, comparable to results obtained on the UNIFI holdout data (0.803, 0.645, and 0.647). The Fleiss kappa score was 0.682, comparable to the inter-rater agreement between two human readers-local and central readers (Fleiss kappa = 0.712). The non-inferiority test (p-value < 0.05) indicated that the AI-computed full colon MES readout was interchangeable to that of human readers. Similar performance was observed for the AI-computed segment-level MES: descending colon, sigmoid colon, and rectum as shown in Table 1. This result demonstrates the model's effectiveness at scoring the segment-level MES despite not being trained with segment level ground truth.

Conclusion

ArgesMES, an AI-based model, underwent successful prospective validation, demonstrating proficiency in automating full colon and segment-level MES scores. ArgesMES has the potential to facilitate rapid, reliable, and reproducible MES scoring at full colon and segment levels in prospective clinical trials.
P217 Rate of undetected dysplasia at colectomy in patients with IBD - What are we missing?
Authors: Centorrino E , Ferrari D , Larson D W , Coelho-Prabhu N
Published: January 2024

Background

Patients with Inflammatory Bowel Diseases (IBD) are at higher risk of developing dysplastic lesions and colorectal cancer (CRC). Despite the use of high-definition endoscopes, dysplasia is not always detected at colonoscopy. This study aims to determine the rate of dysplastic lesions detected only at colectomy in IBD patients and to identify the characteristics of patients with undetected dysplasia.

Methods

We retrospectively identified IBD patients that underwent total or sub-total colectomy at Mayo Clinic, between January 2013 and December 2022. Patients with a confirmed IBD diagnosis, with at least one colonoscopy report prior to surgery available, were included. Data collected was demographics, comorbid conditions, colonoscopy, surgery, and their pathology reports. Concordance between dysplasia found at colonoscopy and dysplasia found at surgery was evaluated, noting dysplasia sites and grade. Patients were then divided into three groups: those with at least one undetected dysplastic lesion at surgery, those with dysplasia detected at colonoscopy and no further lesions at surgery, and those without dysplasia at both.

Results

Seven hundred-four patients were included: 387 (55%) were male, 450 (64%) had ulcerative colitis, 197 (28%) had Crohn’s disease and 57 (8%) had indeterminate colitis.

In 42 patients (6%) dysplasia was undetected at colonoscopy, 136 (19.3%) had dysplasia detected at colonoscopy, and 526 (74.7%) had no dysplasia at both.

In the group with dysplasia detected, 40 patients (30%) had dysplasia only at colonoscopy while 96 (70%) had dysplasia at surgery as well.

Among those with undetected dysplasia, in 17 (40%) dysplasia was identified only at surgery: 14 (82%) had low grade dysplasia and 3 (18%) had cancer. All cancers were stage 1. Three of these patients (18%) had primary sclerosing cholangitis and 4 (23%) had a family history of cancer. In the other 25 patients (60%), dysplasia was detected at colonoscopy but further dysplastic foci were identified at surgery. In 13 (52%) patients dysplasia was upgraded, in 2 (8%) was downgraded and in 10 (40%) the grade was confirmed. Compared to those with detected dysplasia, these patients more frequently had moderate-severe disease activity, and less frequently a prior history of dysplasia. There was no difference in age at surgery, but those with undetected dysplasia had less years of disease at colectomy.

Further results are shown in Table 1.

Conclusion

The rate of dysplastic lesions found at colectomy and missed at colonoscopy is 6%. Dysplastic lesions tend to be undetected when endoscopic disease activity is more severe and regardless of the use of extensive nontargeted biopsies.
P235 Correlation of mental and psychological status to disease activity in patients with Inflammatory Bowel Disease using The Symptom Checklist -90- Revised Questionnaire (SCL90R)
Authors: Abdelaty K
Published: January 2024

Background

Inflammatory Bowel Disease can affect mental health. There is no evidence that stress is a direct cause of the disease. Most Inflammatory Bowel Disease patients describe an emotional impact, mainly feelings of depression and anxiety. Many questionnaires used to assess anxiety in those patients including Symptom Checklist -90-Revised Questionnaire. This research aimed to investigate Correlation of mental and psychological status to disease activity in patients with Inflammatory Bowel Disease using Symptom Checklist -90-Revised Questionnaire.

Methods

The study included one hundred patients (50 Crohn's Disease patients – 50 Ulcerative Colitis patients). Detailed history taking, systemic physical examination, laboratory investigations, Colonoscopy, Symptom Checklist -90-Revised Questionnaire. A self-report psychometric instrument (questionnaire) for every patient.

Results

The mean age of Crohn’s Disease patients was 24,2 years +/- SD 3,6 years. In Ulcerative Colitis patients the mean age was 28,5 years +/- SD 7,3 years. No age or gender relation could be detected with Symptom Checklist -90-Revised Questionnaire score in both groups, The study showed a direct correlation of Crohn's Disease Activity Index (CDAI) and endoscopic activity (Simple Endoscopic Score) (SES) to Symptom Checklist -90-Revised Questionnaire. There was direct correlation of Ulcerative Colitis disease activity (Simple Clinical Colitis Activity Index) (SCCAI) and Endoscopic activity (Ulcerative Colitis Endoscopic Index of Severity) (UCEIS) to Symptom Checklist -90-Revised Questionnaire.

Conclusion

There is a direct correlation of disease activity and Endoscopic activity in Ulcerative Colitis and Crohn's Diseases to Symptom Checklist -90-Revised Questionnaire.
P237 Cognitive debriefing of a patient-reported outcome measure for abdominal pain and loose stool frequency in Crohn’s disease
Authors: Gibble T H , Kosa K , Basnyat B , Martin S , Moses R , Dubinsky M
Published: January 2024

Background

Abdominal pain (AP) and loose stools are key symptoms of Crohn’s disease (CD). Patient-reported AP and loose stool frequency (SF) items comprise two of the three patient-reported items included in the Crohn’s Disease Activity Index. These AP and SF items are referred to as "the PRO" in Lilly’s clinical trials. This study aimed to elicit in-depth information on how patients understand and respond to the PRO.

Methods

Cognitive debriefing interviews were conducted in adults and adolescents (aged 15–17 years) with moderately to severely active CD. Eligible participants self-reported disease severity but had to provide proof that they were diagnosed with CD ≥6 months ago. Participants must have received biologic and/or conventional therapy for CD and must not have had surgery to treat CD. Participants provided feedback on the PRO and described what PRO response options or score changes would reflect meaningful improvement in symptoms or denote successful treatment. Interview transcripts and field notes were analysed using a standard thematic analysis approach.

Results

17 adults and 3 adolescents participated during May–July 2023. Participants had a mean age of 38 (range=17–60) years; 70% (n=14) were female; 70% (n=14) were White. Participants had been diagnosed, on average, 10 (range=0.5–29) years ago. Most participants (n=13, 65%) reported moderate CD severity. All participants interpreted the AP item as intended, found the response options clear and easy to use, and reported that it would be easy to recall their AP severity over 24 hours. Of the 13 participants reporting AP (mild: n=6, 30%; moderate: n=7, 35%), nearly all (n=11, 85%) would consider a 1-level improvement (e.g., ‘mild’ to ‘none’ on the four-level scale) as meaningful. Most participants (n=11, 55%) would consider a treatment successful if their AP was ‘mild’; while many others (n=8, 40%) would need their AP to be completely resolved (i.e., ‘none’). All participants easily understood the SF item, interpreted it as intended, and reported that it would be easy to recall how many very soft or liquid stools they had experienced in a 24-hour period. Participants generally considered a 35.5% decrease in the number of very soft or liquid stools to be a meaningful improvement. On average, participants would consider a treatment successful if they had 1.7 (range=0–5, median=1) very soft or liquid stools per day.

Conclusion

Participants understood and easily completed the PRO. These findings support the content validity of the PRO in adults and adolescents with moderately to severely active CD and provide insights on the amount of change in AP and SF that patients would consider meaningful.
P256 Relationship and sexuality in Inflammatory Bowel Disease: results from a patient questionnaire
Authors: Jäghult S , Bello F , Almer S
Published: January 2024

Background

Health-related quality of life has been studied for almost 30 years in patients with Inflammatory Bowel Disease (IBD). However, the knowledge concerning consequences of illness like fatigue, psychological illness, and relationship and sexuality is still sparse.

The aim of this study was to gather more information about the IBD patient´s view concerning relationship and sexuality and how patients experience the support and help from the healthcare professionals.

Methods

A questionnaire was sent digitally to all members with an IBD diagnosis in the Swedish patient association. The questionnaire contained seven questions. Four of them concerned background data (age, gender, diagnosis, IBD-surgery). The final three questions concerned relationships and sexuality and were qualitatively analyzed with content analysis.

Results

Out of 2274 patients who received the questionnaire, a total of 556 answered (24%). The median age was 55 years of age, 69% were women, 46% had ulcerative colitis, 45% Crohn´s disease, 6% microscopic colitis, and 3% had a mixed form. A total of 36% had undergone surgery due to IBD.

Question 5: "What kind of problems have you experienced regarding relationships and sexuality?" A total of 78% stated some kind of problem. The most common physical problems were pain (14%), incontinence/urgency (11%), and gas/bloating (9%). The most frequent psychological problems were fear of leakage (13%), decreased sexual drive (11%), and loss of energy (8%). Several patients described that their sexual life always needed to be carefully planned, and some described that they avoided having a partner because of difficulties to initiate relationships.

Question 6: "What kind of help and support from the healthcare do you want?" A total of 64% wished that healthcare professionals raised questions concerning relationships and sexuality as an equal natural part as the rest of health status.

Question 7: "Have you spontaneously raised questions concerning relationships and sexuality in your contacts with healthcare professionals?" A total of 84% answered no. Reasons stated were that it was felt uncomfortable, embarrassing, due to lack of time and that other concerns were prioritized. Some patients expressed that they had no contact with their healthcare center at all.

Conclusion

A total of 78% of the patients answering this questionnaire acknowledged that they experienced physical issues and fears concerning relationships and sexuality, mostly due to pain and leakage. A more active support was wanted from 64% of the patients, but only 14% had themselves raised the topic to health care professionals. More knowledge and awareness concerning relationships and sexuality are needed to ensure person-centered care for all IBD-patients.
P260 Clinical-ultrasound comparison of enthesis lesions in inflammatory bowel diseases
Authors: Gainullina G , Kirillova E , Abdulganieva D
Published: January 2024

Background

The objective of study was to compare the frequency of enthesis lesions in pts with inflammatory bowel diseases (IBD) according to clinical examination and ultrasound (US).

Methods

95 IBD pts were prospectively enrolled into the study: 55 pts with ulcerative colitis and 40 - with Crohn's disease. The average age of pts was 32 (26; 37) years. The average duration of the disease was 48 (12; 96) months. During clinical examination, palpation tenderness of 46 enthesis of the upper and lower extremities was assessed in each pt. According to the results of the evaluation, the number of painful entheses was calculated. US examination with power Doppler detected inflammatory (hypoechogenicity of enthesis, thickening of enthesis, presence of vascularization) and structural (erosion, enthesophyte) changes in entheses. US examination included 68 entheses of the upper and lower extremities in each pt.

Results

A total of 4370 entheses were examined clinically. Pain on palpation of entheses was noted in 49 pts (52%). The number of painful entheses was 149 (3.4%). A total of 6460 entheses were examined using US. Enthesites were found in 72 pts (76%), including vascularized enthesites in 35 pts (37%). The total number of identified enthesites was 293/6460 (4.5%), enthesites with vascularization - 62/6460 (1.0%). Structural changes in entheses were common. Erosions were determined in 76 pts (80%), the total number of enthesis erosions was 313/6460 (4.8%). Enthesophytes were detected in 37 pts (39%), the total number of enthesophytes was 91/6460 (1.4%). The number of enthesites detected by US - 72 pts (76%) significantly exceeded the number of clinically painful entheses on palpation - 49 pts (52%) (p=0.0008).

Conclusion

In pts with IBD, according to US, the frequency of detection of enthesis lesions - 72 pts (76%) was significantly higher than in clinical examination - 49 pts (52%).
P263 Clinical-Endoscopic Correlation of Postoperative Recurrence in Surgically Treated Crohn's Disease Patients
Authors: Siham B , amri F , koulali H , zazour A , ismaili Z , Kharrasse G
Published: January 2024

Background

The majority of patients with Crohn's disease (CD) require surgical intervention at some point in their disease course, particularly ileocolic resection. However, the average rate of clinical postoperative relapse is 30% at 3 years and 60% at 10 years. Endoscopic postoperative recurrence precedes clinical recurrence, highlighting the importance of conducting a colonoscopy 6 to 12 months postoperatively to establish the Rutgeerts score,which predicts the risk of clinical recurrence. The aim of this study is to correlate endoscopic findings with the clinical symptoms of these patients.

Methods

We retrospectively analyzed clinical symptoms and Rutgeerts scores of Crohn's disease patients who underwent ileocolic resection during the course of their disease, and followed at the Hepato-Gastroenterology Department of MOHAMMED VI university hospital in Oujda, Morocco, during the period [2018-2023]

Results

Sixty Crohn's disease patients underwent at least one surgical operation during the course of their disease, comprising 25 females and 35 males with a sex ratio (M/F: 1.4). The average age of our patients was 35 years [20-73]. The average time between diagnosis and the first surgery was 4 years. All these patients received postoperative medical treatment before colonoscopy, including azathioprine or methotrexate in 26 patients (43%) and anti-TNF in 34 cases (56%), with an average time of 8 months between surgery and the start of treatment. According to the Montreal classification, the ileocolic form dominated in 88% of cases, with a penetrating phenotype in 40% and a structuring phenotype in 60%. The operative indication was primarily obstructive syndromes in 85% of cases and collections in15%. The average time to perform colonoscopy after surgery was 10 months. During follow-up, 80% of patients were asymptomatic post-surgery, with Rutgeerts scores of I0-I1 in 11(23%) patients, I2 in 13 (27%) cases, I3 in 9 (19%) cases, and I4 in 15 (31%) cases.However, clinical recurrence, characterized by diarrhea, abdominal pain, or Koenig's syndrome, was observed in 20% of patients, with an average postoperative clinical recurrence time of 2 years. The endoscopic findings in these patients revealed Rutgeerts scores of I2 in 4 cases (33%), I3 in 3 cases (25%), and I4 in 5 cases (41%).

Conclusion

In summary, despite postoperative medical management, the risk of clinical recurrence isnotable. Early postoperative colonoscopy, assessing Rutgeerts scores, proves crucial inpredicting clinical recurrence risk. The observed clinical-endoscopic discordance emphasizes the need for a comprehensive approach to monitoring postoperative outcomes in Crohn's disease.
P266 Predictive tissue-based biomarkers in treatment of Inflammatory Bowel Disease with biologicals and small molecules: a systematic review
Authors: Mookhoek A , Sönmez D , Kovacic L , Juillerat P , Misselwitz B , Dawson H
Published: January 2024

Background

The treatment landscape of inflammatory bowel disease (IBD) has changed in the past decade with introduction of new drug classes. For most drugs, only 30% of patients achieve long-term remission. Clinical implementation of predictive biomarkers to support precision medicine is lacking. As the interactions of immune system and microbiome in the colonic mucosa may hold the key to the prediction problem, we performed a systematic review to assess the status of tissue-based biomarkers in the era of biological and small molecule therapies.

Methods

A literature search was performed in Medline, Embase, the Cochrane Library, Web of science and the ECCO abstract database in July 2023. Papers were considered eligible when reporting on biomarkers, extracted from biopsies obtained during colonoscopy, that had predictive value regarding therapy success of a specific non-TNFα biological or small molecule. Two authors independently assessed eligibility and extracted the data.

Results

From 10,141 screened records with 155 papers assessed for eligibility, a total of 43 studies were included. The majority was published in the last 5 years (87%). Data on the clinical history of patients and the interval between biopsy and therapy onset was often lacking, in part while 49% of studies were published as conference abstracts. Heterogeneity in therapy success assessment regarding modality (clinical, endoscopic, and/or histologic) and interval (4-58 weeks) was striking. With 28 studies, vedolizumab is the best investigated drug. Of the 16 studies reporting on gene expression, 7 used data from the GEMINI-I/LTS trials. These studies reported a range from a single predictive gene such as TREM1 and OSM to a classifier of 267 differentially expressed genes. Studies looking at the protein level (n=7) focused mostly on target engagement. In 7 studies, biomarker discovery was performed through histological evaluation, mainly looking at mucosal eosinophil counts. One study looking at the microbiome did not find differences between responders and non-responders of vedolizumab.

Conclusion

Our systematic review shows that tissue-based predictive biomarker discovery in IBD is a young and dynamic field of research. This is reflected by the heterogeneity in how and when therapy success is assessed. Moreover, the various methods to analyze gene expression data yield vastly different results when applied to the same dataset. We therefore propose guideline development to support clinical implementation of predictive biomarkers.
P300 An Expert Delphi Consensus: Early Identification of Patients at Risk of Crohn's Disease in Perianal Fistulas and Abscesses (PREFAB) and Identification and Management of Isolated Perianal Crohn's Disease (ipCD) - Part A, PREFAB
Authors: Munster L , Hanna L N , Dige A , Lundby L , Hart A L , Buskens C J , Tozer P J , van der Bilt J D W
Published: January 2024

Background

In ± 10% of all Crohn’s disease (CD) patients a perianal abscess (PAA) or fistula (PAF) is the manifesting symptom. The delay in diagnosis of CD, from fistula or abscess onset, is very long and associated with worse outcomes. The aim of this Delphi study was to reach consensus on a clinical decision tool to help select patients with raised suspicion of CD in PAA/PAF patients, to identify underlying CD earlier and reduce the diagnostic delay.

Methods

A panel of international experts in the field of proctology and/or Inflammatory Bowel Disease (IBD), consisting of surgeons, gastroenterologists and radiologists were invited to participate in the PREFAB part of this Delphi study. The first round was an electronic survey and the second round a virtual consensus meeting. In the first round, participants were asked to anonymously provide their opinion probing 1) the relevance and use of clinical characteristics (“Red Flags”) suggestive of underlying CD, 2) the use of faecal calprotectin (FCP) as an adjunct for screening for CD and 3) on the diagnostic work-up for IBD in PAA/PAF patients with raised clinical suspicion. In the second round, statements were paired/revised based on the feedback from the first round and presented in a final set of statements. Consensus was predefined as ≥70% agreement.

Results

A total of 30 experts participated in the first round and 25 in the second round (83.3%). Final consensus was reached for 29% of all statements in the first Delphi round and, after adjustments/merging, for all 11 statements (100%) in the second round. Ninety-seven percent of participants agreed that shortening of the delay in diagnosis by using a clinical decision tool could improve outcomes in patients with perianal disease as a first symptom. Consensus was reached on the red flags to be included in the clinical decision tool, on screening of all patients with any perianal fistula (regardless of the complexity, biological behaviour and co-existent perianal symptoms) to identify CD in an early (sub)clinical phase, on referral criteria and on the diagnostic workup and follow up of patients with raised suspicion.

Conclusion

A clinical decision tool for early identification of CD in patients with PAA/PAF as a first symptom could shorten delay in diagnosis and improve outcomes. Global consensus for this tool, including a practical and relevant algorithm for finding or excluding CD in patients with PAA/PAF as a manifesting sign, was reached within two rounds. This clinical decision tool will be validated in 2024 in a large, prospective multicenter study.
P309 Impact of EBV Status on decision making for advanced therapies in IBD Patients
Authors: Robertson H , Thut J , Turnbull J , Whitehead E , Fitzgerald A L , McBride J , Savage R , Wilkinson J , Harper P , Rice J , Pattinson A , Bautista N , Sebastian S
Published: January 2024

Background

The CESAME study suggested that Thiopurines confer increased risk of lymphomas in IBD patients who are naïve to Epstein - Barr virus (EBV) particularly in young males. European Crohn’s and Colitis Organisation (ECCO) guidelines recommend considering EBV screening in individuals prior to initiating immunomodulator therapy. The impact of EBV serology status on decision-making processes regarding advanced therapies in IBD patients is not studied before.

Methods

Consecutive patients initiated on advanced therapies (biologics or small molecules). EBV nuclear and vca IgG status were recorded. The first advanced therapy of the positive and negative patients were compared. Proportion of the negative patients who seroconverted and the time to seroconversion were analysed.

Results

We included 491 patients (M: F 1:14). Median age of patients who had EBV serology done prior to initiating on advanced therapies was 31.5 years (range 5-84 years) .In 41 (8.35%) patients, neither nuclear nor vca IgG antibody were detected at initial screening. The median age of EBV negative patients was 26 years (range 13-51 years).30 of the EBV negative patients were males. Azathioprine/6MP was not initiated in 37 (90.24%) of the EBV negative patients. Re-testing of EBV negative patients were done at a median interval of 28 months (range 3-90 months). 5 of these retested patients (12.2%), seroconverted and in three of this patients Azathioprine was used following seroconversion.

Conclusion

A significant minority of IBD patients are EBV negative when tested as part of pre biologic screening, including in male patients above the age of 25.

Thiopurine therapy was avoided in these patients. Only a fraction of EBV negative patient seroconverted on re-testing. The impact of EBV testing in treatment decision, as well as the attributable costs needs to be evaluated further.
P314 Serum levels of Leucin-Rich α2 Glycoprotein predicts endoscopic mucosal healing of Crohn's disease
Authors: Sonoda A , Okano S , Iwamoto S , Sako M , Fukata M
Published: January 2024

Background

It has been suggested that serum levels of Leucin-Rich α2 Glycoprotein (LRG) correlate with disease activity of Crohn’s disease (CD). Small bowel capsule endoscopy (SBCE) can be performed together with ileo-colonoscopy (ICS) at the same day to assess mucosal healing in patients with clinically quiescent CD. The aim of this study was to determine the usefulness and a cut off value of LRG that indicate mucosal healing in patients with CD.

Methods

Clinically quiescent CD (CDAI<150) patients without perianal lesions received SBCE and ICS at the same day between July 2021 and August 2023 were included. Serum levels of CRP and LRG were measured in the time frame of median 23 days before or after the exam (IQR 14, 43). Endoscopic findings were evaluated by modified simple endoscopic score for CD (mSES-CD) composed of 3 variables (size of ulcers, proportion of ulcer surface and disease affected surface) of each 7 segments (jejunum, upper ileum, lower ileum, right colon, transvers colon, left colon and rectum). Mucosal healing was defined by the mSES-CD score of 0.

Results

Among 51 CD patients enrolled, 88.2% were male with the median age of 20 (IQR 22, 35) and the disease duration of 69 months (IQR 23, 35). History of small or large intestinal resection was found in 15 (29.4%) and 14 (27.4%) cases, respectively. The median CRP and LRG were 0.1 mg/dL (IQR 0.1, 0.4), and 12.3 μg/mL (IQR 8.8, 18.3), respectively. The median mSES-CD was 3 (0,6%), and 20 (39.2%) cases were score 0. There was a high correlation between LRG and CRP levels (p<0.0001, r=0.78), and the cut of value of LRG that indicates negative CRP (< 0.4 mg/dL) was 16.6 μg/mL; area under the curve (AUC) of ROC analysis 0.91, sensitivity 90.0%, specificity 84.8%. In addition, a significant correlation between LRG levels and mSES-CD was found (p< 0.0001, r= 0.65), while no correlation between CRP and mSES-CD (p=0.72, r= 0.27). The cut off value of LRG that indicates mucosal healing was 10.2 μg/mL (AUC 0.915, sensitivity 89.7%, specificity 85.7%) with positive predictive value of 92.9% and negative predictive value of 80.0%.

Conclusion

LRG can be a reasonable biomarker to monitor disease status of CD especially in clinically quiescent patients with small bowel CD. LRG values less than 10.2 μg/mL indicates endoscopic mucosal healing in patients with CD.
P318 Performance of rectosigmoidoscopy and rectoscopy to assess endoscopic and histological healing in ulcerative colitis
Authors: Yzet C , Moreau C , Chatelain D , Meudjo E , Brazier F , Hautefeuille V , Robert C , Decrombecque C , Sarba R , Pichois R , Michaud A , Fumery M
Published: January 2024

Background

Endoscopic and histological healing are associated with improved long term outcomes in ulcerative colitis (UC). Considering all the limitations of endoscopy, we aimed to compare the performance of complete colonoscopy, rectosigmoidoscopy (RS) and rectoscopy to assess endoscopic and histological healing in UC.

Methods

Between January 2021 and January 2023, all consecutive UC patients who underwent complete colonoscopy were prospectively included. Endoscopic activity was assessed by the Mayo Endoscopic Score (MES) on the 5 colonic segment. Endoscopic healing was defined by a MES=0 on all explored segments and histological healing was defined by a NANCY score ≤ 1 (2 biopsies/segments). The correlation between colonoscopy, RS and rectoscopy in terms of endoscopic and histological mucosal was assessed using Cohen's kappa coefficient.

Results

80 patients were included. Thirty-four patients had a MES=0 on all the 5 colonic segments. The correlation between the colonoscopy and RS was almost perfect with an index к of 0.949 for Mayo 0, and к of 0.945 for Mayo 0-1. The correlation between histological healing in RS and colonoscopy was almost perfect (к=0.877, p<0.001). Additionally, the correlation between rectoscopy and colonoscopy for the evaluation of endoscopic[mf1] and histological healing was almost perfect (к=0.826 (p < 0.001) and к=0.8 (p < 0.001), respectively).

Conclusion

RS is sufficient to assess both endoscopic healing and histological healing in UC. With a false negative rate < 10%, rectoscopy is effective to assess endoscopic and histologic healing in UC.
P319 Genetic polymorphism of lactose intolerance in patients with Inflammatory Bowel Disease
Authors: Babayeva-Sadigova G , Guliyev F , Maxmudov U , Hasanov R , Musayev J , Asadova G , Ibrahimli H , Afandiyeva N , Hasanova A , Maharramova T
Published: January 2024

Background

Lactase deficiency is a disorder of lactose absorption in the body due to a deficiency of lactase, an enzyme that helps break down milk sugar. . The most common cause of primary lactase deficiency is due to a polymorphism in the MCM6 gene, which affects the function of the LCT lactase gene. Normal lactose digestibility is associated with the TT genotype, and when thymine is substituted for cytosine (allele C), a decrease in lactase levels in adulthood and impaired lactose digestibility to the point of complete inability to digest lactose should be expected. Understanding the prevalence of lactose intolerance in populations with inflammatory bowel disease may have important implications, preventing unnecessary restrictive diets and thereby helping to prevent future complications, including malnutrition and the occurrence of disorders of phosphorus-calcium metabolism.

Aim Of The Study

to investigate the prevalence of lactose intolerance and to evaluate the possibilities of correlation between genotype and lesion localization in IBD

Methods

Three single nucleotide polymorphisms of the LCT gene: LCT-13910 CC, LCT-13910 CT, LCT-13910 TT were analyzed in the group of patients with IBD (128 patients; UC-62 patients, CD 66 patients) and in the control group (45 patients with IBS).

Results

Baseline patient demographics and genetic analysis scores for lactase deficiency and variants of genetic polymorphism and association with localization of pathological process in IBD are presented in Table 1 and Figure 1.

Conclusion

Thus, the prevalence of LCT-13910 CC was 59.4% (congenital deficiency) and LCT-13910 CT was 31.3% (age-associated deficiency). In 9.4% of patients with IBD, no deficiency was genetically identified. In patients in the control group, LCT-13910 CC was detected in 15.5%, LCT-13910 CT in 42.4%, and LCT-13910 TT in 44.4%. LCT-13910 CC variant was predominant in CD patients with small intestinal lesions (n=41; 95.3% and 62.1%, respectively), in patients with left-sided ulcerative colitis (n=14; 51.8% and 22.6%, respectively) and total lesions in ulcerative colitis (n=12; 70.6% and 19.3%, respectively).Thus, the need for a lactose elimination diet is necessary in cases with small intestinal involvement in CD, and with total and left-sided course in UC.
P328 Ischemic Ulcers Do Not Significantly Impact The Endoscopic Recurrence Score In Crohn’s Disease: A Multicenter Comparative Study After Right-Side Resections For Crohn’s Disease And Colorectal Cancer
Authors: Luglio G , Castiglione F , Orlando A , Solina G , Fichera A , Imperatore N , Lamanda R , Di Girolamo E , Marone P , Delrio P , Tropeano F P , Calabrese G , Cricrì M , Calderone S , Toro B , De Palma G D , Rispo A
Published: January 2024

Background

Post-operative recurrence (POR) is common in patients with Crohn’s disease (CD) who have undergone surgery. Endoscopy, mainly based on Rutgeerts’ score, is crucial for the diagnosis of POR, showing also high prognostic value. More recently, several studies have suggested that the current endoscopic score system could be affected by the ischemic (not inflammatory) nature of some anastomotic ulcers, particularly at the level of the mucosal inverted stapled line, so overestimating the prevalence of the "real" anastomotic POR. However, these studies, based on the comparison between CD patients and subjects undergone right-side resection for colorectal cancer (CRC), included a very small population. Starting from these considerations, we performed a retrospective study aimed to directly compare the prevalence of anastomotic POR in CD with that of patients undergone right-side resection for CRC in a wide population.

Methods

A retrospective study was conducted at four Italian Institutions (2 with a high volume of IBD admissions; 2 with a high volume of CRC admissions). All patients performed endoscopy within 8 months from surgery. We selected all consecutive CD and CRC patients undergone a surgical resection with an anisoperistaltic stapled L-L anastomosis. The diagnosis of POR of CD was made in accordance with the modified Rutgeerts’ score (i0, i1, i2A, i2B, 3, 4). The global prevalence of POR (Rutgeerts’s score ≥2) was recorded. Furthermore, we directly compared the prevalence of the isolated anastomotic ulcers of CD (Rutgeerts i2A) to that detected in CRC patients.

Results

At the end of the study, we enrolled 221 CD patients and 72 CRC subjects. POR was recorded in 127 CD patients (57%). According to the endoscopic grade system, POR was scored as i0: 56 pts (25%), i1: 38 pts (17%); i2A: 42 pts (19%), i2B: 26 pts (12%), i3: 20 pts (9%), i4: 39 pts (18%). In the CRC group, endoscopy detected anastomotic ulcers in 2 out of 72 patients (3%); 1 case (1.4%) of CRC early recurrence was observed. When comparing the prevalence of isolated anastomotic ulcerations in CD (i2A) vs those in CRC patients, the prevalence of ulcerations was significantly higher in CD patients (19% vs 3%; p<0.01; OR=6.3).

Conclusion

Our study confirms the high prevalence of early recurrence in CD patients, highlighting the role of early (within 6-8 months) post-operative endoscopy in CD setting. The prevalence of anastomotic (ischemic) ulcers in CRC patients is very low and, as a consequence, this issue should not represent a real diagnostic matter if shifted into the POR setting of CD. Prospective, multicentre and directly comparative studies are needed to confirm our results.
P334 The longitudinal analysis of fecal microbiota in response to ustekinumab treatment in patients with Crohn’s disease
Authors: Kim J , Kim M K , Yoon A R , Hong S W , Hwang S W , Park S H , Yang D H , Byeon J S , Myung S J , Yang S K , Ye B D
Published: January 2024

Background

Emerging evidence supports that treatment of Crohn’s disease (CD) can alter the intestinal microbiota, which can play a significant role in the pathogenesis and therapeutic outcomes of CD. Ustekinumab (UST) has also been reported to modify the intestinal microbiota during a short-term treatment period. However, the long-term impact of UST treatment on the intestinal microbiota has rarely been studied.

Methods

We prospectively enrolled patients with CD who were planning to start UST treatment and collected fecal samples before (baseline) and after UST administration at week 20 and week 52. Fecal bacterial taxonomic diversity and composition were analyzed through 16S ribosomal ribonucleic acid (rRNA) gene amplicon sequencing. The difference in the intestinal microbiota between clinical remitters and non-remitters defined by Crohn’s disease activity index (CDAI) was investigated, along with the longitudinal changes in the intestinal microbiota.

Results

A total of 124 fecal samples acquired from 43 patients were analyzed (median age 30 years, male 76.7%, median CDAI at baseline 183.2). Clinical remission was observed in 34.9% (n=15/43), 61.0% (n=25/41), and 60.0% (n=24/40) at baseline, week 20, and week 52, respectively. Shannon’s alpha diversity index increased significantly at week 20 and week 52 compared to baseline (both P<0.001). Compared to non-remitters, a significant increase of Shannon’s alpha diversity index was also observed among remitters (P=0.044) across all time points, while no significant difference was noted at each time point. The beta diversity analysis based on the Bray-Curtis distance revealed a significant difference among remitters at week 20 (P=0.027), however, there were no significant differences at other time points. Compared to the baseline, the abundance of the Firmicutes phylum was higher at week 20 (P=0.048) and 52 (P=0.019). The Lactobacillus genus (P=0.042), and Lactobacillus gasseri group (P=0.016) were significantly less abundant in remitters, while the Lachnospiraceae family (P=0.017) was more abundant in remitters. At week 20, Bifidobacterium genus (P=0.027) and Bifidobacterium pseudolongum group (P=0.040) were significantly more abundant in remitter while the Lactobacillus genus was less abundant (P=0.009) in remitter (Figure 1).

Conclusion

The alteration of fecal microbiota after UST treatment may have the potential to serve as a biomarker for predicting clinical remission.

Financial Support

This study was supported by the National Research Foundation of Korea (NRF) grant funded by the Korea government (MSIT) (NRF-2021R1A2C2095096), the grant (2020IT0012) from the Asan Institute for Life Sciences, Seoul, Korea and the grant (CR 2017-4) from CELLTRION PHARM, Inc., Chungcheongbuk-do, Korea.
P336 Exploring Extracellular Matrix Markers in Ulcerative Colitis: Degradation and Formation Insights
Authors: Poulsen A , Riis L B , Pehrsson M , Sørensen L T , Krarup P M , Burisch J , Mortensen J H , Seidelin J B
Published: January 2024

Background

The gold standard for assessing disease activity in ulcerative colitis (UC) is endoscopy, which is uncomfortable for the patient, and only evaluates the superficial layers of the colon. Intestinal extracellular matrix (ECM) remodeling is highly dynamic during disease activity and blood spillover of ECM components might reflect transmural disease burden. The aim of this study was to evaluate baseline serum markers of ECM formation (PRO-C11, PRO-C22, and PRO-C7) and degradation (C7M) to assess disease activity and treatment response in UC.

Methods

Forty-nine UC patients with active disease and 50 healthy controls (HC) were included. All underwent endoscopy and blood sampling at inclusion. UC patients additionally had fecal calprotectin (FCP) measured at baseline and had treatment adjusted at the discretion of the attending physician. Subsequent follow up of UC patients included clinical activity score, FCP, and blood samples at 3 and 6 months as well as an endoscopy at 6 months. Ulcerative Colitis Endoscopic Index of Severity (UCEIS), total Mayo score (TMS), and disease extent (E1-E3) was registered. Response was defined as a reduction from severe to moderate or mild disease based on TMS. If no follow-up endoscopy was performed (n=9), partial Mayo was used. Spearman’s correlation and one-way-ANOVA with Turkey correlation and correction for multiple testing were applied for statistical analysis.

Results

All markers of ECM degradation and formation were elevated in patients with severely active UC measured by both UCEIS and TMS compared to HC (adjusted p<0.0001 for each marker). CM7 and PRO-C22 differentiated moderate from severe UC by TMS (p<0.0001) and UCEIS (p<0.05) (Figure 1A-B). Baseline C7M, PRO-C7, and PRO-C11 correlated with CRP (Spearman’s: r=0.82, p<0.0001; r=-0.45, p=0.0012; and r=-0.33, p=0.032, respectively). None of the markers correlated with FCP. Elevated C7M, PRO-C7, and PRO-C11 levels for E3 could differentiate E3 from E1 (Difference ng/ml: 3.89 (SE of diff: 1.47), 13.15 (4.55), 10.08 (4.09), respectively, all p<0.05) (Figure 1C-E). Remission was achieved in 18/49 patients at 6 months. Both C7M and PRO-22 exhibited acceptable discriminative capabilities at baseline for 6-month TMS between remission and non-remission (AUC 0.72 (95% CI 0.58-0.87) p=0.01 and AUC 0.68 (95% CI 0.53-0.83) p=0.04, respectively) (Figure 1F-G).

Conclusion

This study demonstrates that ECM markers correlate with disease activity, disease extent, and predict future disease outcome in UC. ECM markers hold great promise as they provide a 'window' into transmural tissue remodeling and inflammatory and fibrotic burden, warranting further investigation.