Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis

Completed

Conditions studied: Multiple Sclerosis, Relapsing-Remitting

In brief

Multiple sclerosis (MS) is a chronic immune central nervous system (CNS) disease of unknown cause. Recent studies suggest that gut microbiota could be a trigger for the neuro-inflammation in MS and abnormal gut microbiota composition has been reported in MS patients. These data provided scientific rationale for microbiota-directed intervention, like stool transplant, for the treatment of MS.

Key facts

Study ID

NCT03975413

Run by

Rush University Medical Center

People needed

1

Starts

2018-09-25

Expected to finish

2020-05-01

Last updated by the study team

2020-10-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Older than 18 years of age.
• Diagnosis of relapsing-remitting multiple sclerosis (RRMS) by neurology(primary specialist).
• Presence of active lesions on brain or spinal cord MRI, in the past 1 year prior to baseline.
• MS disease duration greater than 1 year.
• Symptomatic (Active RRMS).
• On MS therapy/medication greater than 4 weeks.

You may not qualify if…

• Newly diagnosed multiple sclerosis.
• Inactive relapsing-remitting multiple sclerosis (RRMS).
• Unstable or no MS therapy/medication use.
• Presence of symptomatically active gastrointestinal diseases such as inflammatory bowel disease or celiac disease (except for hemorrhoids, hiatal hernia, or occasional (˂3 times a week) heartburn)).
• Pre-existent organ failure or co-morbidities as these may change GI flora: a) liver disease (cirrhosis or persistently abnormal AST or ALT that are 2X˃ normal); b) kidney disease (creatinine ˃ 2.0mg/dL); c) uncontrolled psychiatric illness; d) clinically active lung disease or decompensated heart failure; e) known HIV infection; f) alcoholism; g) transplant recipients (other than FMT); h) diabetes
• Severe malnutrition or obesity with BMI ˃ 40.
• Antibiotic and probiotic use (except yogurt) within 4 weeks of enrollment.
• Chronic use of NSAIDS. A washout period of 3 weeks is needed before the subject could be enrolled into the study. Low dose aspirin is allowed.
• Pregnant or lactating women or intention of getting pregnant during the trial period.
• Active infection including untreated latent or active tuberculosis, HIV, hepatitis, syphilis or other major active infection.
• Active symptomatic C. Difficile infection (colonization is not an exclusion).
• Active gastrointestinal condition being investigated (i.e. GI bleeding, colon cancer, active GI workup); history of known or suspected toxic megacolon and/or known small bowel ileus, major gastrointestinal surgery (e.g. significant bowel resection) within 3 months before enrollment (note that this does not include appendectomy or cholecystectomy); or history of total colectomy or bariatric surgery.

Where it is running

• Rush University Medical Center — Chicago, Illinois, United States

Full record on ClinicalTrials.gov

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