NCT07646223Not yet recruitingPhase 2
Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis
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
Source: ClinicalTrials.gov · Last updated 10 Sept 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 1 Oct 2026
- Primary completion date
- 31 Dec 2032
- Lead sponsor
- Tampere University Hospital
- Diseases
- Ulcerative colitis
- NCT number
- NCT07646223
- EU CT number
- 2025-524543-12-00
What you commit to
- Study type: Interventional · Phase 2
- Planned participants: 140
- From 1 Oct 2026 to the primary completion date, 31 Dec 2032
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had a previous allergic reaction to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomycin.
Other illness
- 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
Age
- Under the age of 6 years old.
Other
- Is unable to swallow capsules.
- Pregnancy
Who the study is looking for
- 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.
Age in the registry: 6 years to 15 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Pirkanmaan hyvinvointialue Coordinator of this site? Confirm its status | Tampere | Finland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.