Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis

Launched by RUSH UNIVERSITY MEDICAL CENTER · Jun 3, 2019

Keywords

ClinConnect Summary

A subject (n-of-1) clinically diagnosed with Relapsing Remitting Multiple Sclerosis (RRMS), by Rush University Neurologists, volunteered and provided written informed consent to participate in this study conducted by Rush University Medical Center's department of Digestive Diseases and Nutrition. The RRMS subject underwent a fecal microbiota transplantation (FMT) administered outside the United States, at Taymount Clinic in the Bahamas, for the treatment of their MS. Being one of the investigators' patients, the subject volunteered to donate their stool samples to the Rush University Medica...

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Eligibility criteria

• Inclusion Criteria:
• • 1. Older than 18 years of age.
• • 2. Diagnosis of relapsing-remitting multiple sclerosis (RRMS) by neurology(primary specialist).
• • 3. Presence of active lesions on brain or spinal cord MRI, in the past 1 year prior to baseline.
• • 4. MS disease duration greater than 1 year.
• • 5. Symptomatic (Active RRMS).
• • 6. On MS therapy/medication greater than 4 weeks.
• Exclusion Criteria:
• • 1. Newly diagnosed multiple sclerosis.
• • 2. Inactive relapsing-remitting multiple sclerosis (RRMS).
• • 3. Unstable or no MS therapy/medication use.
• • 4. 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)).
• • 5. 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
• • 6. Severe malnutrition or obesity with BMI ˃ 40.
• • 7. Antibiotic and probiotic use (except yogurt) within 4 weeks of enrollment.
• • 8. 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.
• • 9. Pregnant or lactating women or intention of getting pregnant during the trial period.
• • 10. Active infection including untreated latent or active tuberculosis, HIV, hepatitis, syphilis or other major active infection.
• • 11. Active symptomatic C. Difficile infection (colonization is not an exclusion).
• • 12. 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.