Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis (NCT07646223) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Vancomycin Efficacy in Response to Dysbiosis in Atypical Colitis
Finland140 participantsStarted 2026-08-01
Plain-language summary
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
Who can participate
Age range
6 Years – 15 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.