Vedolizumab effects on gut microbes and symptom improvement in ulcerative colitis
Changes in Intestinal Microecology Before and After Vedolizumab Treatment for Ulcerative Colitis and Correlation With Efficacy
This study will test whether vedolizumab changes gut microbes and metabolites and helps adults with moderate to severe ulcerative colitis.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | vedolizumab, vindolizumab |
| Locations | 1 site (Zhengzhou, Hangzhou) |
| Trial ID | NCT05481619 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults (18 or older) with moderate to severe ulcerative colitis who are candidates for vedolizumab, have not previously received vedolizumab, and have not taken antibiotics or probiotics in the past 4 weeks.
Not a fit: People who are pregnant or breastfeeding, under 18, previously treated with vedolizumab, recently on antibiotics or probiotics, or unable to complete study visits are unlikely to benefit from participating.
Why it matters
Potential benefit: If successful, this could help predict who will respond to vedolizumab and allow more personalized treatment choices for people with ulcerative colitis.
How similar studies have performed: Vedolizumab is an established treatment for ulcerative colitis and small studies have shown treatment-related microbiome and metabolome changes, but using baseline multi-omics profiles to predict response is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Zhengzhou, Hangzhou
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.