Clinical trial NCT05043818: A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Official title: A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inflammatory Bowel Diseases
Keywords: Ulcerative Colitis, Crohn's Disease，Anxiety ， Depression
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2021-09-14
Enrollment: 178
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inflammatory bowel disease diagnosed in the outpatient clinic or hospitalization of our hospital

Brief summary: Inflammatory bowel disease (IBD) seriously affects the quality of life of patients. During treatment, it is found that patients are often accompanied by a certain degree of psychological problems, such as depression, sensitivity, introversion, depression, and pessimistic disappointment. Among them, anxiety and depression are the most common. Through prospective observational research, statistics of the incidence of depression in inflammatory bowel disease in our hospital, comparison of the proportions of each subtype, screening of intestinal biomarkers in IBD patients with depression, and observation of inflammatory bowel disease with different The type and quantity of different intestinal flora in patients with severe depression, and the correlation between intestinal flora and depression.

Detailed description: The subjects voluntarily participated in the study and signed an informed consent form. Follow the steps below:

1. When you come to the hospital or the first to second days of admission, collect general information: ID number, gender, age, height, weight, BMI, complete medical history including a) date of diagnosis, b) degree of disease, c) course of disease , D) previous surgery, e) previous hospitalization, f) comorbidities, g) current symptoms, h) extra-articular manifestations, i) endoscopic data, j) treatment drugs and other data.
2. Scale evaluation (see Annex 1 for details): Screening related scales for anxiety and depression symptoms (PHQ9, SDS, HADS, HAMA, HAMD), inflammatory bowel disease quality of life scale (IBDQ), ulcerative colitis Patient's modified Mayo score/Simplified questionnaire surveys for patients with Crohn's disease such as CDAI score, stool characteristics, abdominal pain degree, and Gastrointestinal Symptom Scale (GSRS);
3. Stool specimens were collected once during the visit to the hospital.
4. The time, frequency and precautions for patients to go to the hospital for examination and follow-up.

This trial is a prospective observational study. When the patient comes to the hospital or on the first to the second day of admission, the subject will be given a full set of scales to check once, and a stool sample will be collected during the treatment. Co., Ltd. performed 16S rRNA sequencing to analyze the results of the bacterial flora once. In this study, there is no need for patients to come to the hospital for follow-up follow-up.

Eligibility criteria: Inclusion Criteria:

1. Definite diagnosis of inflammatory bowel disease【diagnostic criteria reference: (2020)JSGE Evidence-based clinical practice guidelines: inflammatory bowel disease】
2. There is no restriction on men and women, aged 18-65 years old;
3. No complicated other serious diseases such as heart, brain, lung, liver, kidney, etc., no mental illness, and normal communication skills;
4. No antibiotics, Bifidobacterium, Bacillus subtilis and other probiotic preparations have been used within one month;
5. Sign the informed consent form and agree to participate in this research.

Exclusion Criteria:

1. Course of disease \<6 months;
2. Unspecified inflammatory bowel disease.
3. Authors with bipolar disorder, persistent mood disorder, and mania;
4. Patients with malignant tumors;
5. Patients during pregnancy and lactation;
6. Combined with hypertension, diabetes, heart disease, stroke or severe chronic disease (infectious, genetic, metabolic, internal Secretory diseases);
7. Patients who cannot cooperate to complete the study.

Primary outcomes:
measure: PHQ-9 score
timeFrame: 0 week
Secondary outcomes:
measure: SDS score
timeFrame: 0 week
measure: HAMA-score
timeFrame: 0 week
measure: HAMD-score
timeFrame: 0 week
measure: HADS-score
timeFrame: 0 week
measure: GSRS-score
timeFrame: 0 week
measure: Simplified CDAI score
timeFrame: 0 week
measure: Modified Mayo score for UC
timeFrame: 0 week
measure: IBD-QoL
timeFrame: 0 week
Other outcomes:
measure: Intestinal flora
timeFrame: 0 week
Locations:
city: Chongqing
country: China
facility: Department of Gastroenterology, Daping Hospital, The Third Military Medical University
state: Chongqing
Study officials:
affiliation: Army Medical Center of PLA
name: Yanling Wei, MD
role: PRINCIPAL_INVESTIGATOR
References: