NCT05481619RecruitingPhase 4
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
Source: ClinicalTrials.gov · Last updated 25 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 25 Jul 2022
- Start date
- 1 Jan 2021
- Primary completion date
- 1 Jan 2026
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Ulcerative colitis
- NCT number
- NCT05481619
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 30
- From 1 Jan 2021 to the primary completion date, 1 Jan 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- have received prior treatment with vedolizumab.
Other illness
- other conditions that, in the opinion of the investigator, are unsuitable for enrollment or affect the subject's ability to complete the study;
Age
- younger than 18 years of age;
Other
- pregnant or breastfeeding women;
- patients who require the assistance of a surrogate, witness, or who are otherwise unable to complete the trial unaided;
- have taken antibiotics or probiotics within the past 4 weeks;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Zhengzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.