NCT05481619 Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis
| NCT ID | NCT05481619 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 30 participants in total. It began in 2021-01-01 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Yan Chen
PRINCIPAL INVESTIGATOR
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Frequently Asked Questions
Who can join the NCT05481619 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05481619 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05481619 currently recruiting?
Yes, NCT05481619 is actively recruiting participants. Contact the research team at yuqiao@zju.edu.cn for enrollment information.
Where is the NCT05481619 trial being conducted?
This trial is being conducted at Zhengzhou, China.
Who is sponsoring the NCT05481619 clinical trial?
NCT05481619 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The principal investigator is Yan Chen at 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China. The trial plans to enroll 30 participants.
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