Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patien
Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
What it found
The trial ended early for another reason (see below).
Reason given: Primary Investigator passed away.
What was tested
Treatment tested
- Fecal microbiota
Results by group
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
Within 6 months
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| Pre-FMT | 0.082 ng/mL | 0.076 (Standard Deviation) | 10 |
| Post-FMT | 0.093 ng/mL | 0.148 (Standard Deviation) | 10 |
| Pre-FMT | 0.171 ng/mL | 0.186 (Standard Deviation) | 10 |
| Post-FMT | 0.261 ng/mL | 0.524 (Standard Deviation) | 10 |
| Pre-FMT | 0.064 ng/mL | 0.046 (Standard Deviation) | 10 |
| Post-FMT | 0.078 ng/mL | 0.07 (Standard Deviation) | 10 |
| Pre-FMT | 0.026 ng/mL | 0.024 (Standard Deviation) | 10 |
| Post-FMT | 0.024 ng/mL | 0.026 (Standard Deviation) | 10 |
| Pre-FMT | 0.049 ng/mL | 0.035 (Standard Deviation) | 10 |
| Post-FMT | 0.036 ng/mL | 0.023 (Standard Deviation) | 10 |
| Pre-FMT | 0.026 ng/mL | 0.019 (Standard Deviation) | 10 |
| Post-FMT | 0.033 ng/mL | 0.043 (Standard Deviation) | 10 |
| Pre-FMT | 0.091 ng/mL | 0.186 (Standard Deviation) | 10 |
| Post-FMT | 0.084 ng/mL | 0.181 (Standard Deviation) | 10 |
| Pre-FMT | 0.030 ng/mL | 0.038 (Standard Deviation) | 10 |
| Post-FMT | 0.036 ng/mL | 0.054 (Standard Deviation) | 10 |
| Pre-FMT | 0.018 ng/mL | 0.018 (Standard Deviation) | 10 |
| Post-FMT | 0.023 ng/mL | 0.039 (Standard Deviation) | 10 |
| Pre-FMT | 0.414 ng/mL | 0.443 (Standard Deviation) | 10 |
| Post-FMT | 0.559 ng/mL | 0.811 (Standard Deviation) | 10 |
| Pre-FMT | 0.036 ng/mL | 0.039 (Standard Deviation) | 10 |
| Post-FMT | 0.031 ng/mL | 0.042 (Standard Deviation) | 10 |
| Pre-FMT | 0.013 ng/mL | 0.011 (Standard Deviation) | 10 |
| Post-FMT | 0.013 ng/mL | 0.013 (Standard Deviation) | 10 |
| Pre-FMT | 0.123 ng/mL | 0.097 (Standard Deviation) | 10 |
| Post-FMT | 0.086 ng/mL | 0.114 (Standard Deviation) | 10 |
| Pre-FMT | 0.016 ng/mL | 0.017 (Standard Deviation) | 10 |
| Post-FMT | 0.016 ng/mL | 0.024 (Standard Deviation) | 10 |
| Pre-FMT | 0.042 ng/mL | 0.031 (Standard Deviation) | 10 |
| Post-FMT | 0.040 ng/mL | 0.043 (Standard Deviation) | 10 |
| Pre-FMT | 0.428 ng/mL | 0.426 (Standard Deviation) | 10 |
| Post-FMT | 0.425 ng/mL | 0.38 (Standard Deviation) | 10 |
| Pre-FMT | 8.778 ng/mL | 8.549 (Standard Deviation) | 10 |
| Post-FMT | 10.906 ng/mL | 16.971 (Standard Deviation) | 10 |
| Pre-FMT | 0.023 ng/mL | 0.021 (Standard Deviation) | 10 |
| Post-FMT | 0.028 ng/mL | 0.026 (Standard Deviation) | 10 |
| Pre-FMT | 0.055 ng/mL | 0.117 (Standard Deviation) | 10 |
| Post-FMT | 0.056 ng/mL | 0.129 (Standard Deviation) | 10 |
| Pre-FMT | 0.149 ng/mL | 0.153 (Standard Deviation) | 10 |
| Post-FMT | 0.203 ng/mL | 0.342 (Standard Deviation) | 10 |
| Pre-FMT | 1.534 ng/mL | 0.795 (Standard Deviation) | 10 |
| Post-FMT | 1.792 ng/mL | 1.322 (Standard Deviation) | 10 |
| Pre-FMT | 0.156 ng/mL | 0.22 (Standard Deviation) | 10 |
| Post-FMT | 0.198 ng/mL | 0.28 (Standard Deviation) | 10 |
| Pre-FMT | 0.042 ng/mL | 0.033 (Standard Deviation) | 10 |
| Post-FMT | 0.053 ng/mL | 0.036 (Standard Deviation) | 10 |
| Pre-FMT | 0.313 ng/mL | 0.585 (Standard Deviation) | 10 |
| Post-FMT | 0.306 ng/mL | 0.627 (Standard Deviation) | 10 |
| Pre-FMT | 1.190 ng/mL | 2.512 (Standard Deviation) | 10 |
| Post-FMT | 1.704 ng/mL | 2.499 (Standard Deviation) | 10 |
Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.
Safety
| Group | Participants at risk | Serious adverse events | Deaths |
|---|---|---|---|
| Early Intervention | 4 | 0 (0.0%) | 0 |
| Late Intervention | 7 | 0 (0.0%) | 0 |
As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.
What it measured
Main measures
Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients
Within 6 months
Immune response
Other measures (4)
Evaluate Effect of Fecal Microbial Transplantation in Gut Microbiome
Monthly for 6 months
Evaluate Effect of Fecal Microbial Transplantation in Gut Permeability
Baseline, 6 months, 12 months
Evaluate Treatment Clinical Safety: Neurological Exam Using the Expanded Disability Status Scale
Monthly for 6 months
Disability progressionSafetyEvaluate Treatment Safety: MRI to Access Subclinical Disease Activity
Baseline, 6 months and 12 months
MRI lesionsSafety
Who could take part
Relapsing MS · 18 and over
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Background
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.Background
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.Background
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.Background
Lavasani S, Dzhambazov B, Nouri M, Fak F, Buske S, Molin G, Thorlacius H, Alenfall J, Jeppsson B, Westrom 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.Background
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.Background
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.Background
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.Background
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.Background
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.
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History
Started
Aug 2017
Main results due
Nov 2018
Finished
Jan 2019
Results posted
Dec 2019