ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Patients on anti-TNF biologics often seek safe ways to support gut microbial health. This trial tests a prebiotic supplement (2'-FL) for safety and whether it increases beneficial bacteria and butyrate in young people with IBD in remission.
Who Should Pay Attention
Pediatric and young adult patients with Crohn's disease or ulcerative colitis who are in remission on infliximab, infliximab-dyyb, or adalimumab; caregivers; clinicians managing maintenance biologic therapy; researchers interested in microbiome-targeted therapies.
Study Snapshot
Story typeClinical Reference
Trial phasePhase 1, Phase 2
Enrollment128 participants
Study statusCompleted
Source depthTrial registry record
What To Know
The study randomized participants to 1, 5, or 10 g/day 2'-FL versus a 2 g dextrose placebo in a Phase 1/2 dose-ranging design. Participants were aged 11–25 and had to be in remission while receiving stable maintenance infliximab, infliximab-dyyb (biosimilar), or adalimumab.
Primary outcomes included gastrointestinal symptoms measured by the GSRS over 20 weeks, and secondary objectives included microbiome and metabolite changes. Concomitant stable immunomodulators (like azathioprine, mercaptopurine, methotrexate) were allowed if doses were stable.
What this does not say: This is a trial registry record describing study design and planned outcomes; it does not report results, safety findings, or efficacy. Do not interpret registry endpoints as findings.
Keep In Mind
This is a ClinicalTrials.gov record (phase 1/2, interventional) describing the study design and planned outcomes. The registry entry does not present trial results. Note that therapeutic drug monitoring was not required for enrollment but available drug/antibody levels obtained for clinical reasons would be recorded.
Source Details
Review the original publication for the complete reporting, methods, and context.
Clinical trial
Evidence type derived from source or registry metadata.
PublicationClinicalTrials.gov
SponsorChildren's Hospital Medical Center, Cincinnati
Trial IDNCT03847467
Study typeInterventional
Trial phasePhase 1, Phase 2
Enrollment128 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedAug 6, 2026, 12:00 AM
Content availableTrial registry record
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.
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