RecruitingPhase 4NCT05481619

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

Changes in Intestinal Microecology Before and After Vedolizumab Treatment for Ulcerative Colitis and Correlation With Efficacy

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Enrollment

30 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

Ulcerative Colitis

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at how a medication called vedolizumab affects the gut microbiome (the community of bacteria living in the intestines) in people with moderate to severe ulcerative colitis, and whether these microbiome changes relate to how well the treatment works. **You may be eligible if...** - You are 18 or older - You have moderate to severe ulcerative colitis - Your doctor has decided to start you on vedolizumab - You have not previously been treated with vedolizumab - You have not taken antibiotics or probiotics in the past 4 weeks - You stopped any prior biologic therapy at least 12 weeks ago (or have never used one) **You may NOT be eligible if...** - You are under 18 - You are pregnant or breastfeeding - You have taken antibiotics or probiotics within the past 4 weeks - You have previously received vedolizumab - You are unable to complete the study independently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGVedolizumab

Recommended dose in patients with UC: 300 mg intravenously at weeks 0, 2, and 6 and every 8 weeks thereafter. Discontinue vedolizumab at week 14 in patients who do not show treatment benefit.