Autoimmune Diseases Clinical Trial
Official title:
Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
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.
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.
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