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Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients

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ClinicalTrials.gov Identifier: NCT03183869
Recruitment Status : Recruiting
First Posted : June 12, 2017
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Marcelo Kremenchutzky, Lawson Health Research Institute

Brief Summary:

The proposed randomized, open label, with treat as usual control group (standard treatment or any disease modifying drugs), crossover phase II study will be conducted in 40 patients (n=20 per group) with the relapsing forms of multiple sclerosis according to the McDonald 2010 Criteria.

Patients will be randomized into 2 intervention groups. One will receive the FMT from month 1 and for the first 6 months (early intervention group). On the other hand, the other group will be a control group during the first 6 months and will receive the FMT for the last 6 months of the study. Patients will be screened for eligibility based on MS diagnosis and EDSS and if eligible then consented. All qualified patients will not be currently or recently treated with high dose steroids.


Condition or disease Intervention/treatment Phase
Autoimmune Diseases Relapsing Multiple Sclerosis Drug: Fecal microbiota Phase 2

Detailed Description:

At Visit 1, before FMT(fecal microbial transplantation), patients will be evaluated for their vital signs, medical history and concomitant medications. Also before transplantation, patient's stool will be collected to study their microbial profile, blood collected for analysis to evaluate cytokines levels as well as blood DNA bacteria and finally, urinalysis to assess gut permeability (baseline). Other assessments (prior to the first dose of therapy) include an Expanded Disability Status Scale (EDSS), pregnancy test (if applicable), physical exam and ECG. Blood samples are also taken at month 1 in order to establish a baseline for routine chemistry/hematology. After all these assessments FMT will be performed by a trained nurse via a rectal enema.

FMT for the early intervention group will be at V1, 2, 2.1, 2.2, V3 and V4. FMT randomized to late intervention group will be V4, 5, 6, 6.1.6.2, 6.3 and V7

Both groups, at Visit 1, Visit 4 and Visit 7, patients will be instructed to drink lactulose solution and collect the urine throughout the previous night and first thing in the morning. A proper collecting bottle will be provided and will also undergo a contrast-enhanced brain MRI scan at Robarts Institute London Ontario.

Those randomized to the Early Intervention group, will return to the clinic for visit 2, 1 month after the first FMT(fecal microbial transplantation). Another stool sample to evaluate the microbial before the second FMT will be collected and peripheral blood samples for cytokines and blood bacterial DNA analysis. Both groups this same routine procedure repeated at visits 2.1, 2.2, 3, 4, 5, 6, 6.1.6.2, 6.3 and visit 7. Another safety assessment 2 weeks after FMT is to review any adverse events that may have occurred.

Both groups will have an MRI at M1, M6 and M12.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This is a prospective, cross-over, open label, randomized 1:1 early versus delayed groups, interventional [FMT] versus no interventional [no FMT] controlled trial to explore the effects of FMT from a healthy donor to RMS patients and investigate whether this can influence disease activity based on a panel of biological markers.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
Actual Study Start Date : August 24, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Early Intervention
Fecal microbiota via enema at Month 1, 2, 3. 4, 5 and month 6 along with stool, urine and blood collection. At months 7, 8, 9, 10, 11 and 12 only stool, urine and blood collection.
Drug: Fecal microbiota
fecal microbial transplantation
Other Name: fecal microbial transplantation

Active Comparator: Late Intervention
At months 1, 2, 3, 4, 5 and 6, stool, urine and blood collection. Fecal microbiota via enema at month 6, 7, 8, 9, 10, 11and 12 months along with stool, urine and blood collection.
Drug: Fecal microbiota
fecal microbial transplantation
Other Name: fecal microbial transplantation




Primary Outcome Measures :
  1. Effect of fecal microbial transplantation in peripheral blood cytokines within Relapsing Multiple Sclerosis patients [ Time Frame: Within 6 months ]
    Luminex test to evaluate cytokines levels in peripheral blood


Secondary Outcome Measures :
  1. Evaluate effect of fecal microbial transplantation in gut microbiome [ Time Frame: Baseline, 2 weeks, 3 months, 6 months, 26 weeks, 9 months and 12 months ]
    PCR (polymerase chain reaction) to assess blood DNA bacteria

  2. Evaluate effect of fecal microbial transplantation in gut permeability [ Time Frame: Baseline, 6 months, 12 months ]
    Urinalysis to evaluate lactulose and mannitol levels

  3. Evaluate treatment clinical safety: Neurological exam using the Expanded Disability Status Scale [ Time Frame: Baseline, 2 weeks, 3 months, 6 months, 26 weeks, 9 months and 12 months ]
    Neurological exam using the Expanded Disability Status Scale

  4. Evaluate treatment safety: MRI to access subclinical disease activity [ Time Frame: Baseline, 6 months and 12 months ]
    MRI to access subclinical disease activity



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have a confirmed diagnosis of relapsing MS defined by the 2010 Revised McDonald Criteria for the Diagnosis of Multiple Sclerosis
  • Any disease duration will be accepted.
  • Have a baseline EDSS of = or <7.0
  • Older than 18 years of age.
  • Be able to attend all clinic appointments without interruption
  • Patients must be able to understand English sufficiently well to understand and comply with the clinic and medication schedules and procedures.
  • Be willing and able to give written informed consent
  • Negative blood pregnancy test at screening

Exclusion Criteria:

  • Not meeting all of the above inclusion criteria
  • Pregnancy or breastfeeding
  • Current or recent [in the last 90 days] exposure to high dose corticosteroids
  • Ongoing use of antibiotics
  • Standard of care exclusions for MRI scans
  • Presence of a chronic intestinal disease e.g. Celiac, malabsorption, colonic tumor
  • Inability to provide informed written consent.
  • Immunosuppression from transplantation, HIV, cancer chemotherapy or ongoing use of any immunosuppressive agents.
  • Concomitant inflammatory diseases
  • Pregnant women
  • Any contra-indications for MRI. Participants are to be screened by a CMRTO (The College of Medical Radiation Technologists of Ontario) certified MRI Technologist in order to determine the MRI compatibility or exclusion of implantable/external devices according to the manufacturer's safety guidelines. The devises include cerebral aneurysm clips, neuro-stimulator, mechanical heart valves, cardiac stents, IUDs(intrauterine device), vena cava filters, shunts, embolization coils, cochlear implants, non-removable prosthesis/artificial limbs. Contraindications are pacemaker of defibrillator, shrapnel/metallic fragments, previous brain surgery, seizure, severe claustrophobia, weight or body index that will prevent a successful MRI study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03183869


Contacts
Contact: Marcelo Kremenchutzky, MD, FRCP 519-663-3121 marcelo.kremenchutzky@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Centre, University Hospital Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Marcelo Kremenchutzky, MD, FRCP    519-663-3121    marcelo.kremenchutzky@lhsc.on.ca   
Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Marcelo Kremenchutzky, MD, FRCP London Health Science Centre

Publications:

Responsible Party: Marcelo Kremenchutzky, Principal Investigator, Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT03183869     History of Changes
Other Study ID Numbers: MS-FMT-001
First Posted: June 12, 2017    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marcelo Kremenchutzky, Lawson Health Research Institute:
microbiome
multiple sclerosis
microbiota
gut

Additional relevant MeSH terms:
Sclerosis
Multiple Sclerosis
Autoimmune Diseases
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Immune System Diseases