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
children aged 6-15 years
able to swallow capsules
are scheduled for diagnostic endoscopy at Tampere University
has not received oral vancomycin before
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.
Parallel
Oral Vancomycin
DrugOral 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.
Colitis remission
Remission is defined as PUCAI \< 10, fecal calprotectin \< 100 ug/g, and normal bowel wall thickness in all segments of the colon at intestinal ultrasound
Change in ALT levels
Change in the GGT levels
Change in the liver stiffness
Measured using shear wave elastography
Changes in the MRCP findings pre-post OVT
Changes in gut microbiota and gut metabolism
Stool samples will be analyzed for gut microbiota diversity and biopsy samples for gut metabolism (using Olink proteomics)
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Tampere University Hospital
Lead sponsor
Fimlab laboratories
Collaborator
University of Helsinki
Collaborator
This trial is not recruiting at the moment. You can still explore other options: