Oral vancomycin for children with atypical ulcerative colitis or colitis linked to PSC
Tests oral vancomycin added to usual treatment in children with inflammatory bowel disease.
Plain-language title generated from the registry record
Registry title: Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis
Key facts
- Where
- Tampere, FinlandSee the site
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 15 years old?
Source: NCT07646223, who can take part
Where in Finland
- Pirkanmaan hyvinvointialueTampere, FinlandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Tampere University Hospital
- Trial code
- NCT07646223EU 2025-524543-12-00
- Record updated
- 10 September 2026
- Original description
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.Read full original descriptionShow less
The Efficacy of Oral Vancomycin Therapy in Managing Different Phenotypes of Paediatric Inflammatory Bowel Diseases by Correlating Treatment Response to Commensal Microbiota Composition and Function
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
Inclusion: children aged 6-15 years; able to swallow capsules; are scheduled for diagnostic endoscopy at Tampere University; has not received oral vancomycin before; do not have active infection (such as clostridium or other bacteria); has not received new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT.
Exclusion: Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomycin; The presence of PSC without UC, Crohn's disease type of inflammatory bowel diseases; Presence of malignant disease or potential need for liver transplantation within the following 12 months; Known renal insufficiency or chronic renal disease; Under the age of 6 years old; Is unable to swallow capsules; Pregnancy.