Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis

Running, not enrolling · Early Phase 1

Conditions studied: Multiple Sclerosis

In brief

The goal of this pilot study is to determine whether fecal microbial transplant (FMT) has the potential to be an effective, safe and tolerable therapy for the treatment of multiple sclerosis (MS). The investigators plan to gather preliminary data in a small cohort of 10 to 15 adults with MS.

Key facts

Study ID

NCT04096443

Run by

Griffin Hospital

People needed

9

Starts

2019-10-28

Expected to finish

2024-12-30

Last updated by the study team

2024-10-18

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of clinically definite multiple sclerosis (CDMS) by 2017 McDonald Criteria
• Ages between 18 and 55 years, inclusive;
• Expanded Disability Status Score (EDSS) between 1.0 and 6.5.
• Currently untreated with any disease-modifying therapy (DMT) or currently being treated with glatiramer acetate or interferon beta.
• Ability to travel to Griffin Hospital for 8 visits over a 5-month period

You may not qualify if…

• Inability to give consent;
• Non-fluency in English;
• Inability to adhere to the protocol;
• Inability (e.g., dysphagia) to or unwillingness to swallow capsules;
• Active gastrointestinal infection at the time of enrollment;
• Use of antibiotics or corticosteroids within three months of study entry;
• Requiring or anticipating antibiotic use during the four weeks after study entry;
• MS relapse within one month of study entry;
• Previous use of any of the following FDA-approved disease-modifying drugs within 12 months of study entry, including natalizumab, fingolimod, siponimod, ozanimod, teriflunomide, diroximel, ocrelizumab, ofatumumab, and/or dimethyl fumarate; or any of the following off-label therapies, including rituximab and cyclophosphamide;
• Any previous use of the following FDA-approved DMTs, including mitoxantrone, alemtuzumab, and cladribine;
• IV immunoglobulin or plasma exchange within six months prior to study entry;
• Known or suspected toxic megacolon and/or known small bowel ileus;
• Major gastrointestinal surgery (e.g., significant bowel resection) within 3 months prior to enrollment (this does not include appendectomy or cholecystectomy);
• History of total colectomy or bariatric surgery;
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy;
• Anticipated life expectancy of less than six months;
• Concomitant other known autoimmune diseases;
• Concomitant pulmonary, cardiac, gastrointestinal (except as noted above) (Crohns, Colitis, inflammatory bowel, intestinal blockage), hepatic, dermatological or genitourinary disease.
• Moderate to severe dysphagia;
• History of alcohol abuse, as defined by the following criteria:
• Men: 5 or more alcoholic beverages per session or day, or 15 or more per week; Women: 4 or more alcoholic beverages per session or day, or 8 or more per week;
• History of illicit drug abuse, e.g., of cocaine, heroin, PCP, and/or narcotic substances;
• Grade 1 or greater lymphopenia, as measured at baseline/clinical screening;
• Liver Function Tests (LFTs) greater than 1½ times upper limits of normal, as measured at baseline/clinical screening;
• History of use of FMT or microbiome-based products (excluding probiotics) at any time, excluding this study;

Where it is running

• Griffin Hospital — Derby, Connecticut, United States

Full record on ClinicalTrials.gov

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