Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03183869
• Date of registration: 09/05/2017
• Prospective Registration: Yes
• Primary sponsor: Lawson Health Research Institute
• Public title: Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
• Scientific title: Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
• Date of first enrolment: August 24, 2017
• Target sample size: 14
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT03183869
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Canada

Contacts

• Name: Marcelo Kremenchutzky, MD, FRCP
• Affiliation: London Health Science Centre

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autoimmune Diseases

Relapsing Multiple Sclerosis

Intervention(s)

Drug: Fecal microbiota

Primary Outcome(s)

Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients [Time Frame: Within 6 months]

Secondary Outcome(s)

Evaluate Effect of Fecal Microbial Transplantation in Gut Microbiome [Time Frame: Monthly for 6 months]

Evaluate Effect of Fecal Microbial Transplantation in Gut Permeability [Time Frame: Baseline, 6 months, 12 months]

Evaluate Treatment Clinical Safety: Neurological Exam Using the Expanded Disability Status Scale [Time Frame: Monthly for 6 months]

Evaluate Treatment Safety: MRI to Access Subclinical Disease Activity [Time Frame: Baseline, 6 months and 12 months]

Secondary ID(s)

MS-FMT-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 02/12/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03183869