Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple Sclerosis

• Register: ClinicalTrials.gov
• Last refreshed on: 10 July 2023
• Main ID: NCT04096443
• Date of registration: 07/08/2019
• Prospective Registration: Yes
• Primary sponsor: Griffin Hospital
• Public title: Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple Sclerosis
• Scientific title: A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple Sclerosis
• Date of first enrolment: October 28, 2019
• Target sample size: 9
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT04096443
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Early Phase 1

Countries of recruitment

United States

Contacts

• Name: Frederick Browne, MD
• Affiliation: Griffin Hospital

• Name: Joseph B Guarnaccia, MD
• Affiliation: Griffin Hospital

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Diagnosis of clinically definite multiple sclerosis (CDMS) by 2017 McDonald Criteria

2. Ages between 18 and 55 years, inclusive;

3. Expanded Disability Status Score (EDSS) between 1.0 and 6.5.

4. Currently untreated with any disease-modifying therapy (DMT) or currently being
treated with glatiramer acetate or interferon beta.

5. Ability to travel to Griffin Hospital for 8 visits over a 5-month period

Exclusion Criteria:

1. Inability to give consent;

2. Non-fluency in English;

3. Inability to adhere to the protocol;

4. Inability (e.g., dysphagia) to or unwillingness to swallow capsules;

5. Active gastrointestinal infection at the time of enrollment;

6. Use of antibiotics or corticosteroids within three months of study entry;

7. Requiring or anticipating antibiotic use during the four weeks after study entry;

8. MS relapse within one month of study entry;

9. Previous use of any of the following FDA-approved disease-modifying drugs within 12
months of study entry, including natalizumab, fingolimod, siponimod, ozanimod,
teriflunomide, diroximel, ocrelizumab, ofatumumab, and/or dimethyl fumarate; or any of
the following off-label therapies, including rituximab and cyclophosphamide;

10. Any previous use of the following FDA-approved DMTs, including mitoxantrone,
alemtuzumab, and cladribine;

11. IV immunoglobulin or plasma exchange within six months prior to study entry;

12. Known or suspected toxic megacolon and/or known small bowel ileus;

13. Major gastrointestinal surgery (e.g., significant bowel resection) within 3 months
prior to enrollment (this does not include appendectomy or cholecystectomy);

14. History of total colectomy or bariatric surgery;

15. Concurrent intensive induction chemotherapy, radiation therapy or biological treatment
for active malignancy;

16. Anticipated life expectancy of less than six months;

17. Concomitant other known autoimmune diseases;

18. Concomitant pulmonary, cardiac, gastrointestinal (except as noted above) (Crohns,
Colitis, inflammatory bowel, intestinal blockage), hepatic, dermatological or
genitourinary disease.

19. Moderate to severe dysphagia;

20. History of alcohol abuse, as defined by the following criteria:

Men: 5 or more alcoholic beverages per session or day, or 15 or more per week; Women:
4 or more alcoholic beverages per session or day, or 8 or more per week;

21. History of illicit drug abuse, e.g., of cocaine, heroin, PCP, and/or narcotic
substances;

22. Grade 1 or greater lymphopenia, as measured at baseline/clinical screening;

23. Liver Function Tests (LFTs) greater than 1½ times upper limits of normal, as measured
at baseline/clinical screening;

24. History of use of FMT or microbiome-based products (excluding probiotics) at any time,
excluding this study;

25. History of severe anaphylactic or anaphylactoid food allergy;

26. History of solid organ transplantation;

27. Risk for Cytomegalovirus (CMV) or Epstein Barr virus (EBV) associated disease (at
investigator's discretion, e.g., immunocompromised and negative (immunoglobulin gamma)
IgG testing for CMV or EBV);

28. Women who are pregnant, lactating, planning to become pregnant, and/or not using an
effective method of contraception (women of childbearing potential will undergo a
pregnancy test, and will be excluded from the study if results are positive);

29. Any allergies to neomycin or similar antibiotics such as amikacin (Amikin), gentamicin
(Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or
tobramycin (Nebcin, Tobi);

30. Any condition that would jeopardize the safety or rights of the subject, would make it
unlikely for the subject to complete the study, or would confound the study results.

31. Household contacts, including children under the age of 5 years, pregnant women, any
person with an immunocompromised condition or on medications causing immunosuppression
or persons 70 years or older;

32. Failure to document a COVID-19 vaccine series at least two weeks prior to study entry.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: All

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Biological: Fecal microbial transplant (FMT)

Primary Outcome(s)

Change in engraftment of donor microbiome in stool samples [Time Frame: Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)]

Secondary Outcome(s)

Change in neurological status using Kurtzke Functional Systems Scale (FSS) [Time Frame: Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)]

Change in self-reported levels of fatigue assessed using Modified Fatigue Impact Scale (MFIS) [Time Frame: Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)]

Change in neurological status using Kurtzke Expanded Disability Status Scale (EDSS) [Time Frame: Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)]

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] [Time Frame: Day of FMT procedure and 5 time points post-FMT (1 day, 3-7 days, 10-15 days, 40-45 days, 100-110 days), or any time the study team is contacted by subjects who report adverse side effects]

Change in immune markers in blood samples assessed using assays of lymphocyte phenotyping and intracellular cytokines [Time Frame: Pre-FMT and 2 time points post-FMT (40-45 days, 100-110 days)]

Change in self-reported health-related quality of life assessed using the Health Status Questionnaire Short-Form 36 (SF-36) [Time Frame: Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)]

Change in self-reported mental health status assessed using Mental Health Inventory (MHI) [Time Frame: Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)]

Secondary ID(s)

2018-09

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Yale-Griffin Prevention Research Center

Multiple Sclerosis Treatment Center, Derby, Connecticut