Autoimmune Diseases Clinical Trial
Official title:
Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
Verified date | November 2019 |
Source | Lawson Health Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 14 |
Est. completion date | January 25, 2019 |
Est. primary completion date | November 19, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | London Health Sciences Centre, University Hospital | London | Ontario |
Lead Sponsor | Collaborator |
---|---|
Lawson Health Research Institute |
Canada,
Cantarel BL, Waubant E, Chehoud C, Kuczynski J, DeSantis TZ, Warrington J, Venkatesan A, Fraser CM, Mowry EM. Gut microbiota in multiple sclerosis: possible influence of immunomodulators. J Investig Med. 2015 Jun;63(5):729-34. doi: 10.1097/JIM.0000000000000192. — View Citation
Hooper LV, Littman DR, Macpherson AJ. Interactions between the microbiota and the immune system. Science. 2012 Jun 8;336(6086):1268-73. doi: 10.1126/science.1223490. Epub 2012 Jun 6. Review. — View Citation
Kelly CR, de Leon L, Jasutkar N. Fecal microbiota transplantation for relapsing Clostridium difficile infection in 26 patients: methodology and results. J Clin Gastroenterol. 2012 Feb;46(2):145-9. doi: 10.1097/MCG.0b013e318234570b. — View Citation
Kwon HK, Kim GC, Kim Y, Hwang W, Jash A, Sahoo A, Kim JE, Nam JH, Im SH. Amelioration of experimental autoimmune encephalomyelitis by probiotic mixture is mediated by a shift in T helper cell immune response. Clin Immunol. 2013 Mar;146(3):217-27. doi: 10.1016/j.clim.2013.01.001. Epub 2013 Jan 16. — View Citation
Lavasani S, Dzhambazov B, Nouri M, Fåk F, Buske S, Molin G, Thorlacius H, Alenfall J, Jeppsson B, Weström B. A novel probiotic mixture exerts a therapeutic effect on experimental autoimmune encephalomyelitis mediated by IL-10 producing regulatory T cells. PLoS One. 2010 Feb 2;5(2):e9009. doi: 10.1371/journal.pone.0009009. — View Citation
Mielcarz DW, Kasper LH. The gut microbiome in multiple sclerosis. Curr Treat Options Neurol. 2015 Apr;17(4):344. doi: 10.1007/s11940-015-0344-7. — View Citation
Miyake S, Kim S, Suda W, Oshima K, Nakamura M, Matsuoka T, Chihara N, Tomita A, Sato W, Kim SW, Morita H, Hattori M, Yamamura T. Dysbiosis in the Gut Microbiota of Patients with Multiple Sclerosis, with a Striking Depletion of Species Belonging to Clostridia XIVa and IV Clusters. PLoS One. 2015 Sep 14;10(9):e0137429. doi: 10.1371/journal.pone.0137429. eCollection 2015. — View Citation
Tremlett H, Fadrosh DW, Faruqi AA, Hart J, Roalstad S, Graves J, Lynch S, Waubant E; US Network of Pediatric MS Centers. Gut microbiota composition and relapse risk in pediatric MS: A pilot study. J Neurol Sci. 2016 Apr 15;363:153-7. doi: 10.1016/j.jns.2016.02.042. Epub 2016 Feb 20. — View Citation
Wang S, Xu M, Wang W, Cao X, Piao M, Khan S, Yan F, Cao H, Wang B. Systematic Review: Adverse Events of Fecal Microbiota Transplantation. PLoS One. 2016 Aug 16;11(8):e0161174. doi: 10.1371/journal.pone.0161174. eCollection 2016. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients | Luminex test to evaluate the levels of 25 cytokines in peripheral blood pre-fecal transplant and post fecal transplant. Due to early termination of the trial, we didn't meet the number of participants required for statistical analysis; therefore, we analyzed the data pre and post FMT, rather than early and late intervention groups as originally planned. Due to the small sample size there was a large variation between cytokine levels of each participant for pre and post FMT, resulting in large standard deviations. | Within 6 months | |
Secondary | Evaluate Effect of Fecal Microbial Transplantation in Gut Microbiome | PCR (polymerase chain reaction) to assess blood DNA bacteria | Monthly for 6 months | |
Secondary | Evaluate Effect of Fecal Microbial Transplantation in Gut Permeability | Urinalysis to evaluate lactulose and mannitol levels | Baseline, 6 months, 12 months | |
Secondary | Evaluate Treatment Clinical Safety: Neurological Exam Using the Expanded Disability Status Scale | Neurological exam using the Expanded Disability Status Scale | Monthly for 6 months | |
Secondary | Evaluate Treatment Safety: MRI to Access Subclinical Disease Activity | MRI to access subclinical disease activity | Baseline, 6 months and 12 months |
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