Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis
Starting soon · Phase 2
Conditions studied: Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC), Pediatric Inflammatory Bowel Diseases
In brief
The goal of this clinical trial is to learn how oral vancomycin therapy may contribute in treating paediatric inflammatory bowel disease, particularly atypical ulcerative colitis and PSC-associated colitis. It will also give more information on how this treatment affects gut microbiota and metabolism. The main questions it aims to answer are: 1. Does oral vancomycin improve disease activity and lead to remission (based on symptoms, biomarkers, and endoscopy findings)? 2. How does oral vancomycin change gut metabolism? 3. Does different types of colitis respond differently to oral vancomycin? Researchers will compare children receiving oral vancomycin plus standard therapy to those receiving standard therapy alone. The gut metabolisim before and after oral vancmycin will also be compared, as well as to healthy controls and children with typical ulcerative colitis. Participants will: 1. Take oral vancomycin (if assigned) together with conventional treatment for at least 3 months and up to 12 months depending on response 2. Visit the clinic approximately every 3 months for checkups, tests, and monitoring 3. Provide blood, stool, and saliva samples to study disease activity and microbiota activity 4. Undergo clinical assessments such as symptom scoring, imaging, and possibly endoscopy 5. Complete questionnaires about quality of life 6. Be monitored for side effects and treatment response throughout the study period
Key facts
- Study ID
- NCT07646223
- Run by
- Tampere University Hospital
- People needed
- 140
- Starts
- 2026-08-01
- Expected to finish
- 2035-12-31
- Last updated by the study team
- 2026-06-12
Who can join
Age: 6 and older, up to 15. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- The presence of PSC without UC, Crohn's disease type of inflammatory bowel diseases.
- Under the age of 6 years old.
- Is unable to swallow capsules.
- Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomycin.
- Presence of malignant disease or potential need for liver transplantation within the following 12 months.
- Pregnancy
- Known renal insufficiency or chronic renal disease
Where it is running
- Tampere University Hospital — Tampere, Finland
Full record on ClinicalTrials.gov
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