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Title: A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects with Multiple Sclerosis
Status: Current
Topic: Complementary & Alternative Medicine;Multiple Sclerosis
Funding Source: State of Connecticut: Biomedical Research Trust Fund
Funding Period: 2018-2020
Study Design: Investigational pilot study
Purpose:

This study will examine whether changing the bacteria in the gut through a fecal microbial transplant (FMT) can affect the autoimmune process that leads to the development of multiple sclerosis (MS). Using oral capsules approved by the Food and Drug Administration (FDA) for other uses, we will transfer fecal material from healthy persons to persons with MS. The FDA has granted permission for this investigational pilot study.

Further Study Details:

The PRC is conducting this study in collaboration with neurologist Joseph Guarnaccia, MD of the Multiple Sclerosis Treatment Center (MSTC) at Griffin Hospital, who is the principal investigator.

Each participant will make 8 visits to Griffin Hospital in Derby, CT. These will include: a clinical screening; a single procedure of 30 FMT capsules taken by mouth; and 5 other visits for blood and stool samples, medical exams, and surveys. FMT capsules and all study procedures and tests will be provided free of charge.

Eligibility:

Study participants must: (1) be 18 to 50 years of age; (2) have been clinically diagnosed as having MS; (3) be able to walk with or without assistance; (4) not be on immunotherapy (except for interferon beta or glatiramer acetate); and (5) be willing to visit Griffin Hospital 8 times over a 4-month period.

Evaluation: The study team will measure the following: (1) ability to tolerate FMT capsules without vomiting or adverse side effects; (2) changes in immune markers found in blood samples; (3) changes in microbiome of stool samples; (4) changes in self-reported quality of life, mental health status, and levels of fatigue; and (5) changes in MS disease status.

Changed at: 3/27/2020 2:56 PM Changed by: Alex Stackpole
Created at: 3/27/2020 2:56 PM Created by: Alex Stackpole

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