FMT for MS Patients (MS-FMT)

Lawson Health Research Institute

Status and phase: Not yet enrolling; Phase 2

Conditions: Multiple Sclerosis

Treatments: Biological: Fecal Microbial Transplants

Study type: Interventional

Funder types: Other

Identifiers

NCT04150549

MS-FMT 002

Details and patient eligibility

About

This is a placebo-controlled, double-blinded, randomized trial design, whereby all patients are eligible to start an injectable therapy, and then randomized to either placebo or FMT for approximately 1 year.

Full description

Fecal Microbiome Transplants: Patients will undergo pretreatment with Amoxicillin/Clavulinate (or matched placebo) for 5 days followed by a bowel cleanse with PEGLYTE. Patients will undergo allogeneic or autologous fecal transplants. Patients will be dosed with FMT oral capsules approximately 48 hours after antibiotic treatment has stopped. Following the FMT capsule treatment on day 1, patients will be administered a repeat oral capsule or placebo dose at 3 weeks. Oral omeprazole or omeprazole placebo will be given 1 hour prior to the baseline and 3 week dose. This will be done to ensure full engraftment of the transplant.

Participants will be seen at baseline, 3 weeks, 6 weeks, 3 months, 6 months and 12 months. A series of neurological tests will be performed for safety measures. In addition to this, MRIs will be completed at baseline, 6 weeks and 12 months. Blood, urine and stool samples will also be collected for data analysis and safety measures.

Enrollment: 34 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 - 55 years of age
• Have an expanded disability status scale (EDSS) of < 6
• Have a diagnosis of relapsing multiple sclerosis
• Have evidence of radiographic activity within the 12 months on MRI (new/enlarging T2 lesion or gadolinium enhancing lesion)
• Eligible to start/starting an injectable DMT
• Not on a DMT currently and/or not on a DMT in last 6 months
• Ability to swallow capsules

Exclusion criteria

• Unable to provide informed consent
• Does not pass the standard MRI screening questionnaire
• Other disease that can affect GI permeability (such as Inflammatory Bowel Disease, Crohn's disease, ulcerative colitis, indeterminate colitis or microscopic colitis, celiac disease)
• Expected requirement for antibiotics within 3 months (chronic suppressive therapies, elective prosthetic joint insertion)
• Toxic megacolon, small bowel ileus
• Penicillin allergy
• Omeprazole allergy

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

Autologous Transplants

Placebo Comparator group

Treatment:

Biological: Fecal Microbial Transplants

Biological: Fecal Microbial Transplants

Allogeneic Transplants

Active Comparator group

Treatment:

Biological: Fecal Microbial Transplants

Biological: Fecal Microbial Transplants