Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
Condition: Autoimmune Diseases; Relapsing Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Autoimmune Diseases; Sclerosis
Intervention: Fecal microbiota
Intervention description: fecal microbial transplantation
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
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)
Enrollment: 14.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers
Keywords: microbiome; multiple sclerosis; microbiota; gut

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.
    

Eligibility 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