FMT for MS Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 7 November 2022
• Main ID: NCT04150549
• Date of registration: 11/10/2019
• Prospective Registration: Yes
• Primary sponsor: Lawson Health Research Institute
• Public title: FMT for MS Patients MS-FMT
• Scientific title: Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial
• Date of first enrolment: June 2023
• Target sample size: 34
• Recruitment status: Not yet recruiting
• URL: https://clinicaltrials.gov/show/NCT04150549
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Key inclusion & exclusion 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



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

Health Condition(s) or Problem(s) studied

Multiple Sclerosis

Intervention(s)

Biological: Fecal Microbial Transplants

Primary Outcome(s)

Changes in T2 Lesions - MRI [Time Frame: Baseline, 6 weeks, 12 months]

Secondary Outcome(s)

Metabolomics [Time Frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months]

Stool Microbiome [Time Frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months]

Neurofilament Light Serum Levels [Time Frame: Baseline, 6 weeks, 3 months, 12 months]

Blood Brain Barrier - MRI [Time Frame: Baseline, 6 weeks, 12 months]

IgA Microbiota [Time Frame: Baseline, 3 weeks, 6 weeks, and 12 months]

Intestinal Permeability [Time Frame: Baseline, 6 weeks, 12 months]

Secondary ID(s)

MS-FMT 002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors