Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2026-01-01 @ 5:57 PM
Study NCT ID:
NCT03183869
Status:
TERMINATED
Last Update Posted:
2019-12-02
First Post:
2017-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chantelle.graf@sjhc.london.on.ca', 'phone': '519-685-8500', 'title': 'Chantelle Graf, RN', 'phoneExt': '35352', 'organization': 'Lawson Health Research Institute'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year - Nov2017 - Nov2018', 'eventGroups': [{'id': 'EG000', 'title': 'Early Intervention', 'description': '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.\n\nFecal microbiota: fecal microbial transplantation', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 3, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Late Intervention', 'description': '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.\n\nFecal microbiota: fecal microbial transplantation', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 5, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hives', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Difficulty Swallowing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaginal Yeast Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Pre-FMT', 'description': 'Cytokine values before fecal microbial transplants.\n\nFecal microbiota: fecal microbial transplantation'}, {'id': 'OG001', 'title': 'Post-FMT', 'description': 'Cytokine values after fecal microbial transplants.\n\nFecal microbiota: fecal microbial transplantation'}], 'classes': [{'title': 'IL17F', 'categories': [{'measurements': [{'value': '0.082', 'spread': '0.076', 'groupId': 'OG000'}, {'value': '0.093', 'spread': '0.148', 'groupId': 'OG001'}]}]}, {'title': 'GM-CSF', 'categories': [{'measurements': [{'value': '0.171', 'spread': '0.186', 'groupId': 'OG000'}, {'value': '0.261', 'spread': '0.524', 'groupId': 'OG001'}]}]}, {'title': 'IFN Gamma', 'categories': [{'measurements': [{'value': '0.064', 'spread': '0.046', 'groupId': 'OG000'}, {'value': '0.078', 'spread': '0.070', 'groupId': 'OG001'}]}]}, {'title': 'IL-10', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.024', 'groupId': 'OG000'}, {'value': '0.024', 'spread': '0.026', 'groupId': 'OG001'}]}]}, {'title': 'MIP3 Alpha', 'categories': [{'measurements': [{'value': '0.049', 'spread': '0.035', 'groupId': 'OG000'}, {'value': '0.036', 'spread': '0.023', 'groupId': 'OG001'}]}]}, {'title': 'IL-12p70', 'categories': [{'measurements': [{'value': '0.026', 'spread': '0.019', 'groupId': 'OG000'}, {'value': '0.033', 'spread': '0.043', 'groupId': 'OG001'}]}]}, {'title': 'IL-13', 'categories': [{'measurements': [{'value': '0.091', 'spread': '0.186', 'groupId': 'OG000'}, {'value': '0.084', 'spread': '0.181', 'groupId': 'OG001'}]}]}, {'title': 'IL-15', 'categories': [{'measurements': [{'value': '0.030', 'spread': '0.038', 'groupId': 'OG000'}, {'value': '0.036', 'spread': '0.054', 'groupId': 'OG001'}]}]}, {'title': 'IL-17a', 'categories': [{'measurements': [{'value': '0.018', 'spread': '0.018', 'groupId': 'OG000'}, {'value': '0.023', 'spread': '0.039', 'groupId': 'OG001'}]}]}, {'title': 'IL-22', 'categories': [{'measurements': [{'value': '0.414', 'spread': '0.443', 'groupId': 'OG000'}, {'value': '0.559', 'spread': '0.811', 'groupId': 'OG001'}]}]}, {'title': 'IL-9', 'categories': [{'measurements': [{'value': '0.036', 'spread': '0.039', 'groupId': 'OG000'}, {'value': '0.031', 'spread': '0.042', 'groupId': 'OG001'}]}]}, {'title': 'IL-1 Beta', 'categories': [{'measurements': [{'value': '0.013', 'spread': '0.011', 'groupId': 'OG000'}, {'value': '0.013', 'spread': '0.013', 'groupId': 'OG001'}]}]}, {'title': 'IL-33', 'categories': [{'measurements': [{'value': '0.123', 'spread': '0.097', 'groupId': 'OG000'}, {'value': '0.086', 'spread': '0.114', 'groupId': 'OG001'}]}]}, {'title': 'IL-2', 'categories': [{'measurements': [{'value': '0.016', 'spread': '0.017', 'groupId': 'OG000'}, {'value': '0.016', 'spread': '0.024', 'groupId': 'OG001'}]}]}, {'title': 'IL-21', 'categories': [{'measurements': [{'value': '0.042', 'spread': '0.031', 'groupId': 'OG000'}, {'value': '0.040', 'spread': '0.043', 'groupId': 'OG001'}]}]}, {'title': 'IL-4', 'categories': [{'measurements': [{'value': '0.428', 'spread': '0.426', 'groupId': 'OG000'}, {'value': '0.425', 'spread': '0.380', 'groupId': 'OG001'}]}]}, {'title': 'IL-23', 'categories': [{'measurements': [{'value': '8.778', 'spread': '8.549', 'groupId': 'OG000'}, {'value': '10.906', 'spread': '16.971', 'groupId': 'OG001'}]}]}, {'title': 'IL-5', 'categories': [{'measurements': [{'value': '0.023', 'spread': '0.021', 'groupId': 'OG000'}, {'value': '0.028', 'spread': '0.026', 'groupId': 'OG001'}]}]}, {'title': 'IL-6', 'categories': [{'measurements': [{'value': '0.055', 'spread': '0.117', 'groupId': 'OG000'}, {'value': '0.056', 'spread': '0.129', 'groupId': 'OG001'}]}]}, {'title': 'IL-17E', 'categories': [{'measurements': [{'value': '0.149', 'spread': '0.153', 'groupId': 'OG000'}, {'value': '0.203', 'spread': '0.342', 'groupId': 'OG001'}]}]}, {'title': 'IL-27', 'categories': [{'measurements': [{'value': '1.534', 'spread': '0.795', 'groupId': 'OG000'}, {'value': '1.792', 'spread': '1.322', 'groupId': 'OG001'}]}]}, {'title': 'IL-31', 'categories': [{'measurements': [{'value': '0.156', 'spread': '0.220', 'groupId': 'OG000'}, {'value': '0.198', 'spread': '0.280', 'groupId': 'OG001'}]}]}, {'title': 'TNF alpha', 'categories': [{'measurements': [{'value': '0.042', 'spread': '0.033', 'groupId': 'OG000'}, {'value': '0.053', 'spread': '0.036', 'groupId': 'OG001'}]}]}, {'title': 'TNF beta', 'categories': [{'measurements': [{'value': '0.313', 'spread': '0.585', 'groupId': 'OG000'}, {'value': '0.306', 'spread': '0.627', 'groupId': 'OG001'}]}]}, {'title': 'IL-28a', 'categories': [{'measurements': [{'value': '1.190', 'spread': '2.512', 'groupId': 'OG000'}, {'value': '1.704', 'spread': '2.499', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Within 6 months', 'description': "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.", 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Evaluate Effect of Fecal Microbial Transplantation in Gut Microbiome', 'timeFrame': 'Monthly for 6 months', 'description': 'PCR (polymerase chain reaction) to assess blood DNA bacteria', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Evaluate Effect of Fecal Microbial Transplantation in Gut Permeability', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Urinalysis to evaluate lactulose and mannitol levels', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Evaluate Treatment Clinical Safety: Neurological Exam Using the Expanded Disability Status Scale', 'timeFrame': 'Monthly for 6 months', 'description': 'Neurological exam using the Expanded Disability Status Scale', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Evaluate Treatment Safety: MRI to Access Subclinical Disease Activity', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'MRI to access subclinical disease activity', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Early Intervention', 'description': '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.\n\nFecal microbiota: fecal microbial transplantation'}, {'id': 'FG001', 'title': 'Late Intervention', 'description': '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.\n\nFecal microbiota: fecal microbial transplantation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Early Intervention', 'description': '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.\n\nFecal microbiota: fecal microbial transplantation'}, {'id': 'BG001', 'title': 'Late Intervention', 'description': '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.\n\nFecal microbiota: fecal microbial transplantation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-09', 'size': 1701422, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-09-20T13:45', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'This is a prospective, cross-over, open label, randomized 1:1 early versus delayed groups, interventional \\[FMT\\] versus no interventional \\[no FMT\\] controlled trial to explore the effects of FMT from a healthy donor to RMS patients and investigate whether this can influence disease activity based on a panel of biological markers.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'whyStopped': 'Primary Investigator passed away.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-08-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-12', 'studyFirstSubmitDate': '2017-05-09', 'resultsFirstSubmitDate': '2019-09-20', 'studyFirstSubmitQcDate': '2017-06-09', 'lastUpdatePostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-11-12', 'studyFirstPostDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effect of Fecal Microbial Transplantation in Peripheral Blood Cytokines Within Relapsing Multiple Sclerosis Patients', 'timeFrame': 'Within 6 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Evaluate Effect of Fecal Microbial Transplantation in Gut Microbiome', 'timeFrame': 'Monthly for 6 months', 'description': 'PCR (polymerase chain reaction) to assess blood DNA bacteria'}, {'measure': 'Evaluate Effect of Fecal Microbial Transplantation in Gut Permeability', 'timeFrame': 'Baseline, 6 months, 12 months', 'description': 'Urinalysis to evaluate lactulose and mannitol levels'}, {'measure': 'Evaluate Treatment Clinical Safety: Neurological Exam Using the Expanded Disability Status Scale', 'timeFrame': 'Monthly for 6 months', 'description': 'Neurological exam using the Expanded Disability Status Scale'}, {'measure': 'Evaluate Treatment Safety: MRI to Access Subclinical Disease Activity', 'timeFrame': 'Baseline, 6 months and 12 months', 'description': 'MRI to access subclinical disease activity'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'multiple sclerosis', 'microbiota', 'gut'], 'conditions': ['Autoimmune Diseases', 'Relapsing Multiple Sclerosis']}, 'referencesModule': {'references': [{'pmid': '25775034', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26367776', 'type': 'BACKGROUND', '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.'}, {'pmid': '27000242', 'type': 'BACKGROUND', '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.'}, {'pmid': '20126401', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22157239', 'type': 'BACKGROUND', '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.'}, {'pmid': '23416238', 'type': 'BACKGROUND', '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.'}, {'pmid': '25843302', 'type': 'BACKGROUND', '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.'}, {'pmid': '22674334', 'type': 'BACKGROUND', '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.'}, {'pmid': '27529553', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nPatients 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.', 'detailedDescription': "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.\n\nFMT 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\n\nBoth 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.\n\nThose 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.\n\nBoth groups will have an MRI at M1, M6 and M12."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Have a confirmed diagnosis of relapsing MS defined by the 2010 Revised McDonald Criteria for the Diagnosis of Multiple Sclerosis\n* Any disease duration will be accepted.\n* Have a baseline EDSS of = or \\<7.0\n* Older than 18 years of age.\n* Be able to attend all clinic appointments without interruption\n* Patients must be able to understand English sufficiently well to understand and comply with the clinic and medication schedules and procedures.\n* Be willing and able to give written informed consent\n* Negative blood pregnancy test at screening\n\nExclusion Criteria:\n\n* Not meeting all of the above inclusion criteria\n* Pregnancy or breastfeeding\n* Current or recent \\[in the last 90 days\\] exposure to high dose corticosteroids\n* Ongoing use of antibiotics\n* Standard of care exclusions for MRI scans\n* Presence of a chronic intestinal disease e.g. Celiac, malabsorption, colonic tumor\n* Inability to provide informed written consent.\n* Immunosuppression from transplantation, HIV, cancer chemotherapy or ongoing use of any immunosuppressive agents.\n* Concomitant inflammatory diseases\n* Pregnant women\n* 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"}, 'identificationModule': {'nctId': 'NCT03183869', 'briefTitle': 'Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': 'Fecal Microbial Transplantation in Relapsing Multiple Sclerosis Patients', 'orgStudyIdInfo': {'id': 'MS-FMT-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Early Intervention', 'description': '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.', 'interventionNames': ['Drug: Fecal microbiota']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Late Intervention', 'description': '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.', 'interventionNames': ['Drug: Fecal microbiota']}], 'interventions': [{'name': 'Fecal microbiota', 'type': 'DRUG', 'otherNames': ['fecal microbial transplantation'], 'description': 'fecal microbial transplantation', 'armGroupLabels': ['Early Intervention', 'Late Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A 5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Centre, University Hospital', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Marcelo Kremenchutzky, MD, FRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Science Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}