Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis
Status:
Active, not recruiting
Trial end date:
2022-01-01
Target enrollment:
Participant gender:
Summary
In this Phase 1b open-label prospective clinical trial, patients with relapsing-remitting MS
will undergo FMT of FMP30 (donor stool) via colonoscopy and immunological efficacy endpoints
will be assessed at various time points. The active phase of the study will continue for 12
weeks post-FMT with safety and biomarker (engraftment) follow-up for 48 weeks. A parallel
observational control arm of MS patients who otherwise satisfy study inclusion criteria based
on their MS phenotype, demographics, disease duration and prior use of allowable MS
therapies, will be recruited as a comparison observational group to measure stability of
stool and serum immunological measures. The study duration for the Observational Control Arm
is 12 weeks.
Phase:
Phase 1
Details
Lead Sponsor:
Jeffrey Gelfand University of California, San Francisco