Ulcerative Colitis study: Vedolizumab
Official title Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis
ClinicalTrials.gov ID: NCT05481619
What this study is testing
What is Vedolizumab?
An investigational intravenous medicine being studied for ulcerative colitis. It is designed to block specific integrins on white blood cells to reduce gut inflammation.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how the gut bacteria and chemicals in the body change while patients with ulcerative colitis receive vedolizumab, and whether those changes help explain how the drug works.
- Who it's for
- Adults who have ulcerative colitis.
- What's involved
- Participants will receive vedolizumab and provide stool and blood samples that will be analyzed for bacteria and other molecules.
- Phase 4: studies an already-approved treatment
- Time commitment: about 52 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join 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 likely can't join 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Zhengzhou, Hangzhou, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 52 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Zhengzhou, Hangzhou, China. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.