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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05481619
Other study ID # I20210001091
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date January 1, 2021
Est. completion date January 1, 2024

Study information

Verified date July 2022
Source Second Affiliated Hospital, School of Medicine, Zhejiang University
Contact Qiao Yu, phd
Phone 0086-13456820567
Email yuqiao@zju.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date January 1, 2024
Est. primary completion date January 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Vedolizumab
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

Country Name City State
China Second Affiliated Hospital Zhejiang University School of Medicine Zhengzhou Hangzhou

Sponsors (1)

Lead Sponsor Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Remission rate of patients Clinical remission response rates(Mayo score=2) 1 year
Secondary Baseline gut microbial composition and abundance of patients Macro-genome sequencing of stool samples to analyze gut microbial composition and abundance 1 year
Secondary Gut and serum metabolome characteristics of UC patients LC-MS mass spectrometry for faecal samples and serum samples to analyze metabolome characteristics 1 year
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