Cure8 trial brief
This trial tests whether oral vancomycin can help children with atypical ulcerative colitis or PSC-associated colitis and whether changes in gut bacteria or metabolites explain response. If effective and safe, it could offer a microbiome-targeted option for certain pediatric IBD patients.
Pediatric patients with atypical UC or PSC-associated UC, parents and caregivers of children with IBD, pediatric gastroenterologists, and researchers interested in microbiome-based therapies.
This is a phase 2 randomized interventional trial (not yet recruiting) testing oral vancomycin plus conventional medical therapy versus conventional therapy alone in children with atypical ulcerative colitis, PSC-associated colitis, and related pediatric IBD.
The study will measure clinical disease activity (PUCAI), biomarkers (faecal calprotectin), imaging, endoscopy/biopsy, gut microbiota composition, and gut metabolism, and will monitor safety including antibiotic resistance.
Participants will take oral vancomycin for 3–12 months if assigned, with follow-up visits about every 3 months and longer-term follow-up up to 2 years.
What the trial will measure: symptom scores, blood tests (inflammation and liver function), stool and saliva for microbiota and metabolomics, intestinal ultrasound and liver elastography, MRCP in selected patients, and endoscopy with biopsies as indicated.
Safety monitoring includes surveillance for gastrointestinal side effects and vancomycin-resistant organisms. Recruitment and scope: the planned enrollment is 140 pediatric participants aged 6–15 years who are undergoing colonoscopy for suspected IBD and who are classified into atypical UC (randomized), PSC-UC, typical UC, or healthy control groups.
The trial aims both to test efficacy/safety and to explore microbiome and metabolomic changes that may predict response.
This is a trial registry record (phase 2, not yet recruiting) describing planned study design and outcomes—it does not report results. Vancomycin is an antibiotic; the study will monitor for antibiotic-related side effects and the development of resistant bacteria. Findings, safety, and clinical recommendations will depend on trial results when available.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
The study will test whether routine point‑of‑care intestinal ultrasound changes clinical decisions compared with standard monitoring, which could make monitoring less invasive and more responsive if effective.
People with IBD who have no or few symptoms but still have moderate–severe inflammation on endoscopy face uncertainty about whether to switch therapies to aim for endoscopic remission.
Noninvasive monitoring matters for children with UC because endoscopy is burdensome. If ultrasound (and simple measures like bowel wall thickness) can reliably detect moderate-to-severe disease, families may avoid some...
