Clinical trial NCT04150549: FMT for MS Patients
Official title: Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Multiple Sclerosis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2019-11-04
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in T2 Lesions - MRI
timeFrame: Baseline, 6 weeks, 12 months
Secondary outcomes:
measure: Blood Brain Barrier - MRI
timeFrame: Baseline, 6 weeks, 12 months
measure: Neurofilament Light Serum Levels
timeFrame: Baseline, 6 weeks, 3 months, 12 months
measure: Intestinal Permeability
timeFrame: Baseline, 6 weeks, 12 months
measure: IgA Microbiota
timeFrame: Baseline, 3 weeks, 6 weeks, and 12 months
measure: Stool Microbiome
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
measure: Metabolomics
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
measure: Metabolomics
timeFrame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Other outcomes:
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