Clinical trial NCT04818788: Hematological Indices and Fecal Calprotectin Predict Histological Remission in Ulcerative Colitis
Official title: Hematological Indices and Fecal Calprotectin as Predictors of Histological Remission in Ulcerative Colitis Patients Receiving Biological Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Ulcerative Colitis
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-26
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: our study will include ulcerative colitis patients who are indicated to biological therapy at gastro enterology unit in internal medicine department at Assuit university during the period of April 2021 to April 2022 and we will do the following to every patient :

full history including drug history full examination colonoscopy and histological examination before the biological therapy and after 8 weeks and after 25 weeks and after 52 weeks ESR , CRP , Fecal calprotectin and CBC including NLR, PLR and MLR before starting biological therapy and after 8 weeks and after 25 weeks and after 52 weeks

Brief summary: Investigators aimed at investigating the prediction ability of faecal calprotectin to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy Investigators aimed to evaluate the prediction ability of NLR, PLR and MLR to predict mucosal healing and histological remission in ulcerative colitis patients receiving biological therapy.

Investigators evaluate the histological remission in ulcerative colitis patients receiving biological therapy in Assuit university hospital.

Detailed description: Ulcerative colitis (UC) is a chronic relapsing disease that involves the colorectal mucosa. Over the years, the therapeutic target has been upgraded from the resolution of symptoms to deep remission to prevent relapses and complications. The primary therapeutic target to be achieved in patients with UC is both clinical and endoscopic remission . The assessment of histological inflammation has emerged as a promising endpoint in UC . However, the link between histological disease activity and other measures of clinical disease activity is not yet well established . Some authors suggest that the presence of histological inflammation is a better predictor of future clinical relapse than endoscopic activity . Several studies showed that patients with residual microscopic active inflammation seem to be more prone to relapse when compared with patients with normal histology .

Calprotectin is a 36-kDa calcium- and zinc-binding protein, which represents approximately 60% of soluble proteins of granulocyte cytoplasm . Fecal calprotectin (FC) is strongly correlated with both MES and Ulcerative Colitis Endoscopic Score (9, 10). In previous studies, FC was shown to be helpful in predicting sustained clinical remission and mucosal healing during anti-TNF treatment, particularly with IFX and ADA. However, no investigations have been performed to evaluate the predictive value of FC in terms of mucosal healing in a prospective cohort of patients with UC treated with biological therapy. Based on the above background, the aim of the present prospective study is to identify a reliable biomarker able to predict therapeutic effectiveness in UC .

Ulcerative colitis (UC) is a chronic relapsing disease characterized by a neutrophil-mediated inflammation of the gut.

Indeed, European Crohn and Colitis Organization guidelines have highlighted how the grade of neutrophilic infiltration is necessary for the diagnosis of this pathological condition and for the evaluation of histological activity. Thus, colonoscopy is necessary to collect mucosal biopsies and assess neutrophilic infiltration for the diagnosis and during follow-up to evaluate treatment response and predict long-term outcome, although histological healing is still debated. However, colonoscopy is an invasive, costly, and not always well-tolerated examination for patients. Apart from endoscopic interventions, disease severity can be also assessed using less-invasive biomarkers, including blood count.

In these regard the investigators aimed to investigate the ability of prediction of hematological indices including (PLR, NLR and MLR) and fecal calprotectin to predict histological remission in ulcerative colitis patients receiving biological therapy .

Eligibility criteria: Inclusion Criteria:

* 24 patients (males and females at the age between 18 and 55 years) of ulcerative colitis indicated to biological therapy

Exclusion Criteria:

* - Ulcerative colitis pregnant women
* Patient receiving biological therapy for extra intestinal manifestation
* Patients on corticosteroids more than 20 mg as it affects leucocytic count
* Patients under the age of 18 years

Primary outcomes:
measure: Histological remission in ulcerative colitis patients receiving biological therapy
timeFrame: one year
measure: Assessment of fecal calprotectin level in ulcerative colitis patients receiving biological therapy
timeFrame: one year
measure: Assessment of the level of PLR, NLR , MLR in ulcerative colitis patients receiving biological therapy
timeFrame: one year
measure: Ability of hematological indices and fecal calprotectin to predict histological remission
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Bertani L, Rossari F, Barberio B, Demarzo MG, Tapete G, Albano E, Baiano Svizzero G, Ceccarelli L, Mumolo MG, Brombin C, de Bortoli N, Bellini M, Marchi S, Bodini G, Savarino E, Costa F. Novel Prognostic Biomarkers of Mucosal Healing in Ulcerative Colitis Patients Treated With Anti-TNF: Neutrophil-to-Lymphocyte Ratio and Platelet-to-Lymphocyte Ratio. Inflamm Bowel Dis. 2020 Sep 18;26(10):1579-1587. doi: 10.1093/ibd/izaa062.
citation: Magro F, Lopes SI, Lopes J, Portela F, Cotter J, Lopes S, Moreira MJ, Lago P, Peixe P, Albuquerque A, Rodrigues S, Silva MR, Monteiro P, Lopes C, Monteiro L, Macedo G, Veloso L, Camila C, Afonso J, Geboes K, Carneiro F; Portuguese IBD group [GEDII]. Histological Outcomes and Predictive Value of Faecal Markers in Moderately to Severely Active Ulcerative Colitis Patients Receiving Infliximab. J Crohns Colitis. 2016 Dec;10(12):1407-1416. doi: 10.1093/ecco-jcc/jjw112. Epub 2016 May 25.
citation: Bertani L, Blandizzi C, Mumolo MG, Ceccarelli L, Albano E, Tapete G, Baiano Svizzero G, Zanzi F, Coppini F, de Bortoli N, Bellini M, Morganti R, Marchi S, Costa F. Fecal Calprotectin Predicts Mucosal Healing in Patients With Ulcerative Colitis Treated With Biological Therapies: A Prospective Study. Clin Transl Gastroenterol. 2020 May;11(5):e00174. doi: 10.14309/ctg.0000000000000174.
citation: Okba AM, Amin MM, Abdelmoaty AS, Ebada HE, Kamel AH, Allam AS, Sobhy OM. Neutrophil/lymphocyte ratio and lymphocyte/monocyte ratio in ulcerative colitis as non-invasive biomarkers of disease activity and severity. Auto Immun Highlights. 2019 May 15;10(1):4. doi: 10.1186/s13317-019-0114-8. eCollection 2019 Dec.