Actively Recruiting
Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2025-07-25
30
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital Zhejiang University School of Medicine
Zhengzhou, Hangzhou, China, 310000
Actively Recruiting
Research Team
Q
Qiao Yu, phd
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here