| Registry | NCT03183869 |
|---|---|
| Status | Terminated - Primary Investigator passed away. |
| Phase | Phase 2 |
| Study type | Interventional; randomized, crossover, masking: none, treatment |
| Enrollment | 14 (Actual) |
| Sponsor | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's (Other) |
| Conditions | Autoimmune Diseases, Relapsing Multiple Sclerosis |
| Interventions | Fecal microbiota (Drug) |
| Dates | start 2017-08-24, primary completion 2018-11-19, completion 2019-01-25, first posted 2017-06-12, last updated 2019-12-02 |
| Locations | 1 site in Canada |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Early Intervention | Active comparator | Drug: Fecal microbiota | 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. |
| Late Intervention | Active comparator | Drug: Fecal microbiota | 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. |
Sex: All, ages: 18 Years to any, accepts healthy volunteers
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
| Milestone | Early Intervention | Late Intervention |
|---|---|---|
| Started | 4 | 7 |
| Completed | 0 | 2 |
| Not completed | 4 | 5 |
Time frame: 1 year - Nov2017 - Nov2018
| Arm | Deaths | Serious adverse events | Other adverse events |
|---|---|---|---|
| Early Intervention | 0/4 (0.0%) | 0/4 (0.0%) | 3/4 (75.0%) |
| Late Intervention | 0/7 (0.0%) | 0/7 (0.0%) | 5/7 (71.4%) |
| Term | Organ system | Early Intervention | Late Intervention |
|---|---|---|---|
| Nausea | Gastrointestinal disorders | 3/4 | 0/7 |
| Hives | Skin and subcutaneous tissue disorders | 0/4 | 1/7 |
| Hypertension | Cardiac disorders | 0/4 | 1/7 |
| Difficulty Swallowing | Gastrointestinal disorders | 0/4 | 1/7 |
| Vaginal Yeast Infection | Reproductive system and breast disorders | 0/4 | 1/7 |
| Ear Infection | Ear and labyrinth disorders | 0/4 | 1/7 |
| Facility | City | Country | Status |
|---|---|---|---|
| London Health Sciences Centre, University Hospital | London, Ontario | Canada |