Fecal Microbiota Transplantation (FMT) of FMP30 in Relapsing-Remitting Multiple Sclerosis

PHASE1Active, not recruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

November 16, 2018

Primary Completion Date

August 1, 2024

Study Completion Date

August 1, 2024

Conditions
Relapsing Remitting Multiple Sclerosis
Interventions
DRUG

FMP30 Donor Stool

FMP30 is manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.

PROCEDURE

Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool

Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30), obtained from the non-profit stool bank OpenBiome, will be administered via colonoscopy in patients with Relapsing-Remitting Multiple Sclerosis. FMT dosage via colonoscopy may include a lower amount of transplanted stool at the discretion of the study gastroenterologist if there are any peri-procedural safety or technical considerations. Total FMT dose (in milliliters) will be documented.

OTHER

Observational Control

Subjects, 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.

Trial Locations (1)

94158

UCSF Multiple Sclerosis Center, San Francisco

All Listed Sponsors
lead

Jeffrey Gelfand

OTHER