Study of the Effect of Vedolizumab on Intestinal Microecological Changes and Its Efficacy in the Treatment of Ulcerative Colitis

  • STATUS
    Recruiting
  • End date
    Jan 1, 2024
  • participants needed
    30
  • sponsor
    Second Affiliated Hospital, School of Medicine, Zhejiang University
Updated on 9 August 2022
antibiotics
monoclonal antibodies
inflammatory bowel disease
vedolizumab
crohn's disease
Accepts healthy volunteers

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.

Description

Stool and blood samples etc. were taken from a cohort of patients with ulcerative colitis treated with Vedolizum at the Department of Gastroenterology, Second Affiliated Hospital of Zhejiang University School of Medicine as well as from a cohort of normal volunteers. Stool and blood samples from UC patients were analyzed at baseline and at 14, 30, and 52 weeks after starting treatment. Analysis of changes in gut microbial composition and abundance, gut and serum metabolome characteristics during 52 weeks of treatment in patients with UC. A model for predicting the efficacy of vedolizumab treatment by baseline gut microbial composition and abundance, and gut and serum metabolomic characteristics in patients with ulcerative colitis was developed in conjunction with clinical information from patients in the cohort. Based on the model developed, clinical and gut microbial composition and abundance, gut and serum metabolomics data from other UC patients published in public databases were combined to confirm the results already found using the UC cohort at our center.

Details
Condition Ulcerative Colitis
Treatment Vedolizumab
Clinical Study IdentifierNCT05481619
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University
Last Modified on9 August 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
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