Multiple SclerosisPhase 2MS-FMTNCT04150549
FMT for MS Patients
A Phase 2 study testing Fecal Microbial Transplants in people with Multiple Sclerosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Fecal Microbial Transplants
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jun 2023to Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial
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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Fecal Microbial Transplants
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbial TransplantsBiological
Healthy donor stool will be processed and placed into capsules.
Fecal Microbial TransplantsBiological
Participants stool will be processed and placed into capsules.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Transplants | Placebo comparator | Not described Receives: Biological: Fecal Microbial Transplants |
| Allogeneic Transplants | Active comparator | Not described Receives: Biological: Fecal Microbial Transplants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in T2 Lesions - MRI
Assess the number of new/enlarging/gad enhancing T2 lesions. We will be comparing baseline to 6 weeks and 6 weeks to 12 months.
Measured: Baseline, 6 weeks, 12 months
Secondary outcomes (7)
Blood Brain Barrier - MRI
We will assess the integrity of the blood brain barrier through MRI from baseline to 6 weeks and 6 weeks to 12 months.
Measured: Baseline, 6 weeks, 12 months
Neurofilament Light Serum Levels
As a biomarker of neuronal damage neurofilament light chain levels will be detected. Peripheral blood will be collected in appropriate tubes at baseline, 6 weeks, 3 months and 12 months and processed for serum.
Once collected all samples will be sent to the University of Ottawa where a Simoa NfL assay will be undertaken on their Simoa Analyzer.
Patients with multiple sclerosis have been shown to have increased intestinal permeability, likely due to a reduction in butyrate-producing bacteria. A decrease in butyrate producing bacteria has been shown to be associated with increased intestinal permeability. Relapsing-remitting MS patients have been shown to have increased intestinal permeability, which may allow dietary and microbial antigens from the intestinal lumen to pass into the blood stream and cause autoimmune responses in MS patients. This may prime the immune system to develop a humoral response to certain bacteria.
Measured: Baseline, 6 weeks, 3 months, 12 months
Intestinal Permeability
Small Intestine Permeability: Mannitol/Lactulose administration will be used and urine will be collected to measure small intestine permeability. For small intestine permeability patients will be instructed to drink lactulose solution and collect the urine throughout the night and first thing in the morning. A proper collecting bottle will be provided. Once the urine sample bottle reaches the laboratory University Hospital the total volume will be measured and an aliquot of 30mL total, 10mL in each sterile urine container (no other additives) will be separated and stored at -20C and sent on dry ice to Dr. Meddings laboratory at Calgary, Alberta. All biological material will be transported according to biosafety regulations.
Measured: Baseline, 6 weeks, 12 months
IgA Microbiota
IgA Microbiota analysis: IgA bound bacteria will be detected and sorted (magnetic beads or flow cytometry) using anti-IgA (pan-IgA, detect monomer and secreted multimer (Miltenyi clone: IS11-8E10). Sorted IgA bound bacteria will be stored, and the DNA extracted in one batch at the end of the study. Changes in the composition of IgA bound bacteria for each patient will be determined using the previously mentioned methods. (Rojas, et al. 2018; Planer, et al. 2016)
Measured: Baseline, 3 weeks, 6 weeks, and 12 months
Stool Microbiome
Gut microbiota analysis before and after FMT: Toilet paper samples will be collected from patients' at baseline and 1-2 days before each scheduled appointment (Al et al. 2018). Patients will store the toilet paper inside of DNA free plastic bags and keep them at 4 °C in the refrigerator until the time of their appointment (alternatively, the samples can be mailed in to the lab, but one method must be chosen for all of the samples collected). Toilet paper samples will be collected from the FMT donor every time they drop off a stool sample for donation. DNA from the toilet paper samples will be extracted in one batch at the end of the study and sent for Illumina Mi-Seq next-generation sequencing of the V4 region of the 16S rRNA gene. Changes in the composition of gut bacteria will be determined using custom R scripts.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Metabolomics
Metabolomics: Serum will be collected for metabolomic analysis. Metabolomics can be used to identify biomarkers of MS and may provide us with information about which patients are more likely to respond to FMT therapy. Butyrate producing bacteria have been shown to be in lower relative abundance in MS patients and concentrations of short-chain fatty acids in stool and will be investigated before and after FMT.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Metabolomics
Metabolomics: Urine will be collected for metabolomic analysis. Metabolomics can be used to identify biomarkers of MS and may provide us with information about which patients are more likely to respond to FMT therapy. Butyrate producing bacteria have been shown to be in lower relative abundance in MS patients and concentrations of short-chain fatty acids in stool and will be investigated before and after FMT.
Measured: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2019
- Study startJun 2023 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Silverman, MD, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04150549
- Sponsor's protocol ID
- MS-FMT 002
- Acronym
- MS-FMT
- Status last verified
- Oct 2022
- First submitted
- 11 Oct 2019
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbial Transplantation for Relapsing Multiple Sclerosis Patients - a Placebo-controlled, Double-blinded, Randomized Trial
- ClinicalTrials.gov ID
- NCT04150549
- Acronym / sponsor ID
- MS-FMT / MS-FMT 002
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jun 2023 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 4 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Transplants | Placebo comparator | Biological: Fecal Microbial Transplants |
| Allogeneic Transplants | Active comparator | Biological: Fecal Microbial Transplants |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbial TransplantsHealthy donor stool will be processed and placed into capsules. | Biological | Allogeneic Transplants |
| Fecal Microbial TransplantsParticipants stool will be processed and placed into capsules. | Biological | Autologous Transplants |
Primary outcome
Changes in T2 Lesions - MRI
Time frame: Baseline, 6 weeks, 12 months
Assess the number of new/enlarging/gad enhancing T2 lesions. We will be comparing baseline to 6 weeks and 6 weeks to 12 months.
7 secondary outcomes
Blood Brain Barrier - MRI
Time frame: Baseline, 6 weeks, 12 months
Neurofilament Light Serum Levels
Time frame: Baseline, 6 weeks, 3 months, 12 months
Intestinal Permeability
Time frame: Baseline, 6 weeks, 12 months
IgA Microbiota
Time frame: Baseline, 3 weeks, 6 weeks, and 12 months
Stool Microbiome
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Metabolomics
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Metabolomics
Time frame: Baseline, 3 weeks, 6 weeks, 3 months, 6 months, 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fecal Microbial Transplants in people with Multiple Sclerosis, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in T2 Lesions - MRI (time frame: Baseline, 6 weeks, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.