FMT of FMP30 for Multiple Sclerosis
(MS-BIOME Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJeffrey Gelfand

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Jeffrey Gelfand

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Adults aged 18-60 with relapsing-remitting multiple sclerosis (MS) who haven't used MS disease modifying therapies recently, or have had a 12-week break from them. Participants must show recent MS activity, be able to walk (with limitations), and test positive for Epstein-Barr Virus. Women of childbearing age need a negative pregnancy test and agree to use contraception. People can't join if they've taken certain medications recently, are pregnant, have progressive MS, active gut conditions, or any other health issues that could interfere with the study.

Inclusion Criteria

You have not taken any medication to treat multiple sclerosis (MS) or you stopped taking it at least 12 weeks ago.

You are between 18 and 60 years old when you get checked for the study.

You have been diagnosed with relapsing-remitting multiple sclerosis (MS) according to specific guidelines.

+8 more

Exclusion Criteria

Prior use of specified medications

No oral or IV antibiotics within specified timeframes

You have taken diuretics like furosemide (Lasix) within 1 week before starting the oral antibiotics.

+13 more

Participant Groups

This trial is testing whether transplanting stool from a donor (FMT of FMP30) into patients' intestines via colonoscopy can affect their immune system in a way that helps control MS symptoms. The main part lasts for 12 weeks with follow-up for almost a year. There's also an observational group not getting the treatment but being monitored as comparison.

2Treatment groups

Experimental Treatment

Active Control

Group I: Interventional FMT Treatment ArmExperimental Treatment2 Interventions

After providing written informed consent, subjects will undergo screening and baseline assessments of stool and blood sampling, questionnaires, physical examination, MS rating scales, and MRI. Subjects will then initiate an oral antibiotic regimen for 5 days to precondition the gut for the Fecal Microbiota Transplantation (FMT) of FMP30 donor stool and optimize engraftment of the FMP30 donor stool microbiome. Following standard bowel preparation for colonoscopy, subjects will undergo the FMT procedure by an experienced gastroenterologist. Subjects will return for scheduled assessments and follow-up MRI for 12 weeks, with additional safety and biomarker follow-up for 36 weeks. The active study time is designed to be short (12 weeks active phase) to minimize time not on other MS disease modifying therapy (DMT). This arm of the study will last for approximately 52 weeks total (4 weeks of screening + 12 weeks active treatment phase + 36 weeks of safety follow up).

Group II: Observational Control ArmActive Control1 Intervention

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. After providing written informed consent, subjects will undergo screening and baseline assessments, including collection of blood and stool samples, demographic data collection, concomitant medication review, and an MS Relapse assessment. At week 2, subjects will mail in stool samples with a prepaid air bill and packaging. Weeks 4, 8, and 12 assessments will include concomitant medication review, relapse assessment, and blood and stool collection. The duration of the study for the observational control arm will last for 12 weeks. All study procedures will be performed at the University of California, San Francisco.