Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis

• Status: Recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

Inflammatory bowel disease is a group of chronic, non-specific inflammatory diseases of the intestinal tract whose etiology has not yet been fully elucidated, including ulcerative colitis and Crohn's disease. Vedolizumab, a novel biologic agent, is a recombinant humanized monoclonal antibody that specifically antagonizes intestine-selective α4β7 integrins on the surface of leukocyte subsets, thereby preventing migration of leukocyte subsets from the blood to the intestinal mucosa and reducing local inflammation in the gut. In this study the investigators propose to build on an existing cohort and analyse, by means of a multi-omics approach, the baseline gut microbial composition and abundance, intestinal and serum metabolome characteristics of UC patients and their changes during treatment, to predict the functional mechanisms by which these changing characteristics influence the therapeutic response to vindolizumab.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Vedolizumab

Criteria

Inclusion Criteria:

1. 18 years of age or older, with moderate to severe ulcerative colitis, with an indication for vedolizumab treatment;

2. Consent to participate in the study, read and sign the informed consent form;

3. No previous treatment with vedolizumab;

4. Never undergone biologic therapy or at least suspended previous biologic therapy for more than 12 weeks;

5. Not taking antibiotics or probiotics within the past 4 weeks.

Exclusion Criteria:

1. younger than 18 years of age;

2. pregnant or breastfeeding women;

3. patients who require the assistance of a surrogate, witness, or who are otherwise unable to complete the trial unaided;

4. other conditions that, in the opinion of the investigator, are unsuitable for enrollment or affect the subject's ability to complete the study;

5. have taken antibiotics or probiotics within the past 4 weeks;

6. have received prior treatment with vedolizumab.