Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis
Phase 4 · Testing Vedolizumab · 1 site · Second Affiliated Hospital, Zhejiang University, School of Medicine
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Vedolizumab (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis.
It is single-blind: participants do not know which group they are in.
Phase 4 studies look at treatments that are already approved, to learn more about how they work in everyday use.
Who can join
- Ages 18 and older
- Any sex
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- 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;
Plus 2 more requirement(s). There are also 6 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 30 participants are expected to take part.
- Start date: 2021-01-01.
- Main results expected around 2026-01-01 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Remission rate of patients (1 year)
In the researchers’ words
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…
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 4 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis |
| Lead sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Enrollment | 30 (estimated) |
| Start date | 2021-01-01 |
| Primary completion (est.) | 2026-01-01 |
| First posted | 2022-08-01 |
| Last updated | 2025-07-25 |
| Official title | Changes in Intestinal Microecology Before and After Vedolizumab Treatment for Ulcerative Colitis and Correlation With Efficacy |
| ClinicalTrials.gov ID | NCT05481619 |
Interventions
- Vedolizumab (Drug)
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.
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Second Affiliated Hospital Zhejiang University School of Medicine | Zhengzhou, Hangzhou | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.