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
Second Affiliated Hospital, School of Medicine, Zhejiang University
30 participants
Jan 1, 2021
INTERVENTIONAL
Conditions
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
Inclusion Criteria5
- 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.
Exclusion Criteria6
- 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.
Interventions
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.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05481619