Vedolizumab effects on gut microbes and symptom improvement in ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Researchers will collect stool and blood samples from adults with moderate to severe ulcerative colitis before treatment and at 14, 30, and 52 weeks after starting vedolizumab. They will apply a multi-omics approach, including gut microbiome sequencing and serum/gut metabolomic profiling, to track molecular and microbial changes over time. Clinical response data will be combined with molecular profiles to build a predictive model of vedolizumab response, and results will be compared and validated using public datasets and samples from healthy volunteers. The goal is to link baseline microbial and metabolomic features with treatment outcomes.

Why it matters

Who can join: the full rules

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.

Where it's running

• Second Affiliated Hospital Zhejiang University School of Medicine
  Zhengzhou, Hangzhou, China Recruiting

Study contacts

• Principal investigator: Yan Chen — 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
• Study coordinator: Qiao Yu, phd
• Email: yuqiao@zju.edu.cn
• Phone: 0086-13456820567

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.