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

Korábbi kezelés

• Use of antibiotics or corticosteroids within three months of study entry;
• 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;
• Any previous use of the following FDA-approved DMTs, including mitoxantrone, alemtuzumab, and cladribine;
• IV immunoglobulin or plasma exchange within six months prior to study entry;
• Major gastrointestinal surgery (e.g., significant bowel resection) within 3 months prior to enrollment (this does not include appendectomy or cholecystectomy);
• Concurrent intensive induction chemotherapy, radiation therapy or biological treatment for active malignancy;
• Concomitant other known autoimmune diseases;
• Concomitant pulmonary, cardiac, gastrointestinal (except as noted above) (Crohns, Colitis, inflammatory bowel, intestinal blockage), hepatic, dermatological or genitourinary disease.
• Failure to document a COVID-19 vaccine series at least two weeks prior to study entry.

Más betegség

• Active gastrointestinal infection at the time of enrollment;
• History of total colectomy or bariatric surgery;
• 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;
• History of illicit drug abuse, e.g., of cocaine, heroin, PCP, and/or narcotic substances;
• History of use of FMT or microbiome-based products (excluding probiotics) at any time, excluding this study;
• History of severe anaphylactic or anaphylactoid food allergy;
• History of solid organ transplantation;
• 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);
• Any allergies to neomycin or similar antibiotics such as amikacin (Amikin), gentamicin (Garamycin), kanamycin (Kantrex), paromomycin (Humatin, Paromycin), streptomycin, or tobramycin (Nebcin, Tobi);
• 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.

Életkor

• 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;

Egyéb

• Inability to give consent;
• Non-fluency in English;
• Inability to adhere to the protocol;
• Inability (e.g., dysphagia) to or unwillingness to swallow capsules;
• Requiring or anticipating antibiotic use during the four weeks after study entry;
• MS relapse within one month of study entry;
• Known or suspected toxic megacolon and/or known small bowel ileus;
• Anticipated life expectancy of less than six months;
• Moderate to severe dysphagia;
• Grade 1 or greater lymphopenia, as measured at baseline/clinical screening;
• Liver Function Tests (LFTs) greater than 1½ times upper limits of normal, as measured at baseline/clinical screening;
• 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);

• Diagnosis of clinically definite multiple sclerosis (CDMS) by 2017 McDonald Criteria
• Ages between 18 and 55 years, inclusive;
• Expanded Disability Status Score (EDSS) between 1.0 and 6.5.
• Currently untreated with any disease-modifying therapy (DMT) or currently being treated with glatiramer acetate or interferon beta.
• Ability to travel to Griffin Hospital for 8 visits over a 5-month period