ClinicalTrials.gov
Cure8 trial brief
Why This Matters
Researchers hope to identify which donor microbes and host factors determine whether FMT microbes take hold, and whether engraftment predicts clinical benefit in conditions including recurrent C. difficile infection and ulcerative colitis.
Better predictors could improve who gets FMT and how donors or preparatory regimens are chosen.
Who Should Pay Attention
Researchers studying the microbiome or FMT, clinicians offering or referring for FMT (gastroenterologists), and patients interested in FMT for rCDI or UC.
Study Snapshot
Story typeClinical Reference
Trial phaseNA
Enrollment90 participants
Study statusRecruiting
Source depthTrial registry record
What To Know
This is a ClinicalTrials.gov interventional study (recruiting) investigating multi-omics determinants of donor microbiome engraftment after fecal microbiota transplantation (FMT) across cohorts including recurrent C. difficile infection, ulcerative colitis, and metabolic syndrome.
The protocol includes pre-FMT antibiotics, an initial colonoscopic FMT followed by oral frozen FMT capsules, longitudinal collection of blood, stool, and colonic biopsies, and multi-omic analyses at multiple timepoints up to 360 days.
The study aims to map host–microbe interactions (including virome and mycobiome), metabolites, and host immune/genetic factors that may predict engraftment and clinical outcomes. The trial emphasizes repeated sampling (stool, blood, biopsies) and combined delivery (colonoscopy plus capsules) with donor consistency.
Practical details such as antibiotic preconditioning (vancomycin, neomycin + bacitracin) and biopsy schedule are specified in the record. The record is a trial registry entry describing planned methods and endpoints; it does not report results.
It is useful to people tracking upcoming research on FMT mechanisms but does not provide clinical findings or treatment guidance.
Keep In Mind
This is a clinical trial registry entry describing the study design and planned measurements rather than results. Any findings will need peer-reviewed publication before they can change practice. The protocol uses antibiotic preconditioning and combined colonoscopy plus capsule delivery, which may differ from FMT approaches used elsewhere.
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
SponsorCatholic University of the Sacred Heart
Trial IDNCT06992453
Study typeInterventional
Trial phaseNA
Enrollment90 participants
Indexed viaClinicalTrials.gov
Source typeTrial registry record
PublishedOct 26, 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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