FMT for MS Patients
Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial
We could not find results for this trial
What it found
We found no results in the registry or in papers.
What was tested
Treatment tested
- Fecal Microbial Transplants
Placebo
- Fecal Microbial Transplants
What it measured
Main measures
Changes in T2 Lesions - MRI
Baseline, 6 weeks, 12 months
MRI lesions
Other measures (6)
Blood Brain Barrier - MRI
Baseline, 6 weeks, 12 months
MRI lesionsNeurofilament Light Serum Levels
Baseline, 6 weeks, 3 months, 12 months
Blood or spinal fluid markersImmune responseIntestinal Permeability
Baseline, 6 weeks, 12 months
SafetyIgA Microbiota
Baseline, 3 weeks, 6 weeks, and 12 months
Stool Microbiome
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Metabolomics
Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Blood or spinal fluid markers
Who could take part
Relapsing MS · 18 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
History
Started
Jun 2023
Main results due
May 2025
Finished
Aug 2025