Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis
Recruiting now · Phase 4
Conditions studied: Ulcerative Colitis
In brief
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.
Key facts
- Study ID
- NCT05481619
- Run by
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- People needed
- 30
- Starts
- 2021-01-01
- Expected to finish
- 2026-01-01
- Last updated by the study team
- 2025-07-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 18 years of age or older, with moderate to severe ulcerative colitis, with an indication for vedolizumab treatment;
- Consent to participate in the study, read and sign the informed consent form;
- No previous treatment with vedolizumab;
- Never undergone biologic therapy or at least suspended previous biologic therapy for more than 12 weeks;
- Not taking antibiotics or probiotics within the past 4 weeks.
You may not qualify if…
- younger than 18 years of age;
- pregnant or breastfeeding women;
- patients who require the assistance of a surrogate, witness, or who are otherwise unable to complete the trial unaided;
- other conditions that, in the opinion of the investigator, are unsuitable for enrollment or affect the subject's ability to complete the study;
- have taken antibiotics or probiotics within the past 4 weeks;
- have received prior treatment with vedolizumab.
Where it is running
- Second Affiliated Hospital Zhejiang University School of Medicine — Zhengzhou, Hangzhou, China (enrolling)
Full record on ClinicalTrials.gov
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