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

A Pilot Study of Oral FMT (Fecal Microbial Transplant) in Subjects With Multiple Sclerosis

CompletedEarly phase 1MS (type not specified)NCT04096443

We could not find results for this trial

What it found

No results found

We found no results in the registry or in papers.

This trial finished 22 months ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Fecal microbial transplant (FMT)

What it measured

Main measures

  • Change in engraftment of donor microbiome in stool samples

    Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)

Other measures (7)

  • Change in immune markers in blood samples assessed using assays of lymphocyte phenotyping and intracellular cytokines

    Pre-FMT and 2 time points post-FMT (40-45 days, 100-110 days)

    Immune response

  • Change in neurological status using Kurtzke Functional Systems Scale (FSS)

    Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)

    Disability progressionVisionFatigueWalking and mobilityPhysical functionBladder, bowel and sexual function

  • Change in neurological status using Kurtzke Expanded Disability Status Scale (EDSS)

    Pre-FMT and 4 time points post-FMT (3-7 days, 10-15 days, 40-45 days, 100-110 days)

    Disability progression

  • Change in self-reported health-related quality of life assessed using the Health Status Questionnaire Short-Form 36 (SF-36)

    Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)

    PainQuality of life (reported by participants)

  • Change in self-reported mental health status assessed using Mental Health Inventory (MHI)

    Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)

    Mood and sleep

  • Change in self-reported levels of fatigue assessed using Modified Fatigue Impact Scale (MFIS)

    Pre-FMT and 3 time points post-FMT (10-15 days, 40-45 days, 100-110 days)

    Thinking and memoryFatigue

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    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

    Safety

Who could take part

MS (type not specified) · 18 to 55 · EDSS 1.0 to 6.5

Show the full 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.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

The goal of this pilot study is to determine whether fecal microbial transplant (FMT) has the potential to be an effective, safe and tolerable therapy for the treatment of multiple sclerosis (MS). The investigators plan to gather preliminary data in a small cohort of 10 to 15 adults with MS.

Papers

    Loading reviews and guidelines…

    History

      1. Started

        Oct 2019

      2. Main results due

        Dec 2024

      3. Finished

        Dec 2024

      Assembled by software from public sources.