Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis
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.
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 Medical Center
 Gastrointestinal (GI) tissue repository for microbiota interrogation at the following time
 points: before FMT (baseline), 3, 13, 26, 39, 52 weeks (1 year) after FMT, to determine the
 impact on their microbiota composition and sustainability of the change. The subject also
 agreed to donate their blood during the above stated time points to see if FMT affected
 markers of bacteria translocation and systemic inflammation. The subject also agreed to have
 their GI symptoms, diet, sleep, and MS related symptoms (rating scales or questionnaires),
 MRI (brain & spine), as well as their gait metric activity objectively assessed to see if the
 FMT affects these symptoms and whether any observed improvement is sustained, in this
 proof-of-concept study. Based on this research, the investigators hypothesize that the FMT
 will significantly altered the overall microbial community structure to promote the growth of
 short chain fatty acid (SCFA)-producing beneficial bacteria, which in turn could potentially
 improve the MS subject's health outcomes, neurological symptoms, and walking metrics over
 time. More clinical trials (larger sample size) will be needed to study the potential of FMT
 for the treatment of MS and to examine the long term effects. FMT is an emerging treatment
 approach for MS. The donor selection, the separation of fecal bacteria, the frequency of FMT,
 the way of infusion, the long-term safety, and efficacy are still uncertain and need to be
 examined.
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.