Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis
Phase 2 · Testing Oral Vancomycin · 1 site · Tampere University Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Oral Vancomycin (a drug) as a possible treatment. Condition(s) listed: Ulcerative Colitis (UC), Primary Sclerosing Cholangitis (PSC) and Pediatric Inflammatory Bowel Diseases.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
Phase 2 studies test whether a treatment shows signs of working, and keep checking safety, in a larger group of people with the condition.
Who can join
- Ages 6 to 15
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 140 participants are expected to take part.
- The study has 5 groups.
- Start date: 2026-10-01 (planned).
- Main results expected around 2032-12-31 (estimate from the record).
- 1 study site listed in Finland.
Groups in this study
- Children with ulcerative colitis and confirmed PSC receiving OVT and conventional treatment (listed as: experimental group)
- Children with atypical UC without confirmed PSC receiving OVt and conventional treatment (listed as: active comparator group)
- Children with atypical UC without confirmed PSC receiving conventional treatment only (listed as: no-intervention group)
- Children with typical UC without confirmed PSC receiving conventional treatment only (listed as: no-intervention group)
- Children without IBD (listed as: no-intervention group)
Main thing being measured
- Colitis remission (3 to 6 months)
In the researchers’ words
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.
Words you might see
- Endoscopy: a camera exam inside the digestive tract.
- Remission: a period when the disease is quiet or under control.
General definitions, not specific to this trial.
This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Phase 2 |
| Study type | Interventional |
| Conditions | Ulcerative Colitis (UC); Primary Sclerosing Cholangitis (PSC); Pediatric Inflammatory Bowel Diseases |
| Lead sponsor | Tampere University Hospital |
| Collaborators | Fimlab laboratories; University of Helsinki |
| Enrollment | 140 (estimated) |
| Start date | 2026-10-01 |
| Primary completion (est.) | 2032-12-31 |
| First posted | 2026-06-12 |
| Last updated | 2026-09-10 |
| Official title | 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 |
| ClinicalTrials.gov ID | NCT07646223 |
Interventions
- Oral Vancomycin (Drug)
Oral vancomycin will be given 50 mg/ kg in three divided doses up to 500 mg x 3/ day for at least 3 months. In responding children, the treatment will be continued for 6(-12) months depending on the timing if possible follow-up colonoscopy.
Full eligibility criteria (from the record)
Inclusion criteria. * 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 Criteria: * 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
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Tampere University Hospital | Tampere | Finland |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.