Oral vancomycin for treating atypical gut inflammation in children
The efficacy of oral vancomycin therapy in different phenotypes of paediatric inflammatory bowel diseases in correlation with gut microbiota composition
Queensland Children's Hospital
63 participants
Jan 1, 2025
Interventional
Conditions
Summary
This study investigates disease behaviour of PSC-UC and treatment resistant aypical UC presenting similar features to PSC-UC yet without confirmed PSC, before and after therapy with OVT, We compared pre-post OVT clinical presentation and endoscopic findings, and corraleted them to pre-post OVT gut and saliva microbiota composition and function. The gut and saliva microbiota will also be compared to healthy controls. We plan for at least 12 months of follow-up, and will observe crucial time points such as relapses and remissions in more details. In our hypothesis, OVT would induce changes in gut microbiota composition and function, leading to different treatment responses in different patinet, based on these changes.
Eligibility
Inclusion Criteria6
- Children aged 3-17 years old with established diagnosis (of PSC-UC or conventional medical treatment resistant atypical UC: endoscopy and biopsies confirmed IBD (in PSC-UC and atypical UC); magnetic resonance cholangio pancreatography (MRCP) and/or liver biopsy confirmed PSC (in PSC-UC), MRCP ruled out PSC in atypical UC without PSC.
- Has nor received OVT preciously, but planning to be commenced on OVT for at least 3 months (or if starting with Pediatric Randomized trial of Antibiotics in acute Severe Colitis (PRASCO) - a cocktail of antibiotics for three weeks including oral vancomycin, that will be continued for at least 3 months) for treating PSC-UC or atypical UC resistant to conventional medical treatment as mentioned in the guidelines, and not for treating Clostridium difficile infection..
- Patients and/or their guardians have given an informed consent.
- No new interventions (medications or new conventional therapies) for treating IBD was given within the past 4 weeks before starting OVT.
- For healthy participants:
- Children aged between 3-17 years old without inflammatory bowel diseases with similar background and age-related physical development status to the patients.
Exclusion Criteria4
- PSC without UC, and Crohn’s disease type of IBD.
- Previous allergic reactions to vancomycin (such as vancomycin allergy) and/or other related antibiotics similar to vancomysin.
- Presence of malignant disease or potential need for liver transplantation within the following 12 months.
- For healthy controls: presence of chronic illness requiring long-term medications, use of antibiotics within the past 6 months.
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Interventions
Brief name: Oral vancomycin therapy (OVT) International Non-proprietary Name (INN): vancomycin - the dose administered: 50 mg/kg/day (max 1500 mg/day) in three divided doses daily - the duration of administration: minimum of 3 months. After three months, physician will address the response. If non-responsive, OVT will be ceased. If responsive, then OVT will be continued for 6 to 12 months depending on previous history of challenges in achieving remission. - the mode of administration: oral solution or capsule - adherence will be monitored during clinical follow-up visits by attending physician, and during dispensing prescription renewal by pharmacist
Locations(1)
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ACTRN12624001372572