NCT05043818

A Clinical Study on the Screening of Intestinal Biomarkers in IBD Patients With Depression

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 178 (estimated)
• Sponsor: Third Military Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
OTHER	—	This study is an observational study and does not involve intervention.When the patient comes to the hospital or on the first to the second day of admission, the subject will be given a full scale check once（Screening related scales for anxiety and depression symptoms (PHQ9, SDS, HADS, HAMA, HAMD), inflammatory bowel disease quality of life scale (IBDQ), modified Mayo score for patients with ulcerative colitis/ simplified CDAI score for patients with Crohn's disease , Stool characteristics, degree of abdominal pain, gastrointestinal symptom scale (GSRS), etc.）. The stool sample will be collected once and 16S rRNA sequencing.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2021-09-14
• Last updated: 2021-09-14

Locations

1 site across 1 country: China