Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients

• Status: Terminated
• Trial end date: 2019-01-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lawson Health Research Institute

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