Fecal Microbiota Transplantation (FMT) in Multiple Sclerosis

NCT ID: NCT03975413

Last Updated: 2020-10-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-25
• Study Completion Date: 2020-05-01

Brief Summary

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.

Detailed Description

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

N=1 MS patient

Single-Arm, Non-Randomized, Time Series, Single-Subject Study. Observational study of the FMT intervention.

Single subject studies are based on repeated observations within an individual over time and are acknowledged as an important research method for generating scientific evidence about the health or behavior of an individual. This design is desirable when the available patient pool is limited and thus it is not optimal to randomize participants to a control arm. The subject serves as his/her own control, rather than using another individual/group.These designs are used primarily to evaluate the effect of a variety of interventions in early stage clinical research development.

Fecal Microbiota Transplantation (FMT)

Intervention Type: OTHER

Longitudinal FMT study: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week

Interventions

Fecal Microbiota Transplantation (FMT)

Longitudinal FMT study: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week

Intervention Type: OTHER

Other Intervention Names

Taymount Clinic

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Ali Keshavarzian

Professor and Director of Digestive Diseases & Nutrition

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali Keshavarzian, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center

Chicago, Illinois, United States

Countries

United States

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Other Identifiers

18082009

Identifier Type: -

Identifier Source: org_study_id