Changes in Intestinal Microecology Before and After Vedolizumab Treatment for Ulcerative Colitis and Correlation With Efficacy

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Second Affiliated Hospital Zhejiang University School of Medicine
RECRUITING
Zhengzhou
Contact Information
Primary
Qiao Yu, phd
yuqiao@zju.edu.cn
0086-13456820567
Time Frame
Start Date: 2021-01-01
Estimated Completion Date: 2026-01-01
Participants
Target number of participants: 30
Treatments
Active_comparator: Group of UC patients treated with vedolizumab
Generic Name:vedolizumab Specification:300mg/bottle Dosage and Method of Administration:Usual adult dose for ulcerative colitis.300 mg IV every 30 minutes at weeks 0, 2, and 6, then every 8 weeks
No_intervention: Normal control group
On the basis of the exclusion criteria, there are no significant intestinal inflammatory, autoimmune or neoplastic disorders.
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University

This content was sourced from clinicaltrials.gov