Ignite Creation Date:
2025-12-24 @ 1:31 PM
Ignite Modification Date:
2025-12-29 @ 10:35 AM
Study NCT ID:
NCT06333795
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069467', 'term': 'Fecal Microbiota Transplantation'}], 'ancestors': [{'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The study is blinded throughout the active study period, both the patient and investigator are blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will undergo 2 interventions. For the first intervention participants are randomised 1:1 for either Active FMT or placebo For the second intervention, all participants receive active treatment.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2024-03-05', 'studyFirstSubmitQcDate': '2024-03-20', 'lastUpdatePostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of adverse events (AE) severity grade 2 or more assessed by CTCAE v5.0. during the first week after intervention (FMT or placebo).', 'timeFrame': 'The first week after treatment.', 'description': 'Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.'}], 'secondaryOutcomes': [{'measure': 'Patient-reported treatment outcome on symptoms', 'timeFrame': 'The first week after treatment.', 'description': 'Based on self-reported data from the bowel habit diary.'}, {'measure': 'Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention.', 'timeFrame': 'One week after each treatment', 'description': 'Mild adverse events (grade 1) following FMT or placebo assessed by (Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0) CTCAE v5.0.\n\nThe CTCAE grades adverse events (AEs) based on severity:\n\nGrade 1: Mild, asymptomatic, or mild symptoms; no intervention needed. Grade 2: Moderate; requires minimal intervention; affects age-appropriate activities.\n\nGrade 3: Severe or medically significant, not immediately life-threatening; may require hospitalization.\n\nGrade 4: Life-threatening; urgent intervention needed. Grade 5: AE-related death. Note: Some AEs may not have all five grades available.'}, {'measure': 'Patient-reported outcomes from questionnaires.', 'timeFrame': 'At Baseline and 4 weeks after Intervention 1 & 2', 'description': 'Change in Gastrointestinal syndrome rating scale - irritable bowel version questionnaire (GSRS-IBS)'}, {'measure': 'Patient-reported outcomes from questionnaires.', 'timeFrame': 'At Baseline and 4 weeks after Intervention 1 & 2', 'description': 'Change in Wexner incontinence score.'}, {'measure': 'Patient-reported outcomes from questionnaires.', 'timeFrame': 'At Baseline and 4 weeks after Intervention 1 & 2', 'description': 'Change in UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0)'}, {'measure': 'Patient-reported overall symptom burden', 'timeFrame': 'Each week for a total of 26 weeks.', 'description': 'The patients self-reported the severity of symptoms and their impact on daily life each week on a scale from 1-5. 1 being little to no burden, 5 being most severe.'}, {'measure': 'Objective measures from the wireless motility capsule.', 'timeFrame': 'At baseline', 'description': 'Transit time through the small intestine.'}, {'measure': 'Objective measures from the wireless motility capsule.', 'timeFrame': 'At baseline', 'description': 'Colonic transit times'}, {'measure': 'Objective measures from the wireless motility capsule.', 'timeFrame': 'At baseline', 'description': 'Total gastrointestinal transittimes'}, {'measure': 'Objective measures from the wireless motility capsule.', 'timeFrame': 'At baseline', 'description': 'Ph drop from the small intestine to the colon'}, {'measure': 'Objective measures from the low-dose CT scan.', 'timeFrame': 'At baseline and 4 weeks after first intervention', 'description': 'Volume of the a) small intestine and b) the colon. Volume of gas in a) the small intestine and b) the colon.\n\nChanges in the gas volume in the small intestine and colon.'}, {'measure': 'Breath Test', 'timeFrame': 'At baseline and 4 weeks after first intervention', 'description': 'Changes in the rise of hydrogen and methane measured in breath test'}, {'measure': 'Faecal microbiota composition', 'timeFrame': 'At baseline and between each treatment, up to 4 weeks after last intervention', 'description': 'Changes in faecal microbiome composition. Alfa and beta diversity determined by sequencing of the intestinal microbiome.'}, {'measure': 'Faecal-calprotectin', 'timeFrame': 'At Baseline and 4 weeks after Intervention 1 & 2', 'description': 'Percentual change in faecal-calprotectin from before intervention to 4 weeks after each intervention.'}, {'measure': 'Blood plasma proteomics', 'timeFrame': 'At baseline and between each treatment, up to four weeks after last intervention.', 'description': 'Changes in blood immunological parameters (including proteins) from baseline and between each treatment, at 4 weeks after intervention.'}, {'measure': 'Blood plasma Fibrosis markers', 'timeFrame': 'At baseline and between each treatment, up to four weeks after last intervention.', 'description': 'Changes in blood immunological parameters (including markers of fibrosis) from baseline and between each treatment, at 4 weeks after intervention.'}, {'measure': 'Blood parameters', 'timeFrame': 'At baseline and between each treatment, up to four weeks after last intervention.', 'description': 'Changes in blood immunological parameters (including circulating cytokines) from baseline and between each treatment, at 4 weeks after intervention.'}, {'measure': 'Health-related Quality of life', 'timeFrame': 'At baseline and 4 weeks after Intervention 1 & 2', 'description': 'Changes in Health-related Quality of life assessed with (EQ-5D-5L). Each of the five dimensions comprising the EQ-5D descriptive system is divided into five levels of perceived problems: LEVEL 1: indicating no problem LEVEL 2: indicating slight problems LEVEL 3: indicating moderate problems LEVEL 4: indicating severe problems LEVEL 5: indicating unable to/Extreme problems\n\nAn EQ-VAS from 0-100 is added, 100 being the best possible health.'}, {'measure': 'Patient perception of FMT treatment satisfaction', 'timeFrame': 'At 4 weeks after interventions 1 & 2', 'description': 'Patient perception of FMT treatment satisfaction was assessed by 7-point Likert scale for patients. 1: no benefits from treatment to 7 being very satisfied with treatment.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Faecal Microbiota Transplantation (FMT)', 'Diarrhea', 'Systemic Sclerosis', 'Chronic Diarrhea'], 'conditions': ['Diarrhea', 'Systemic Sclerosis']}, 'descriptionModule': {'briefSummary': 'This clinical trial aims to assess the safety and effectiveness of faecal Microbiota Transplantation (FMT) in improving chronic diarrhea symptoms among patients with systemic sclerosis.', 'detailedDescription': 'The present study aims to assess the feasibility, pilot efficacy, and safety of FMT for patients with Systemic Sclerosis.\n\nParticipants will undergo two interventions in this present study.\n\nIn the first intervention, participants are randomized 1:1 for either active FMT or Placebo. This first intervention consists of two doses of FMT with a 3-7 day gap.\n\nIn the second intervention, all participants receive 1 dose of active FMT treatment.\n\nThis study design allows researchers to evaluate the safety of FMT in this patient group, and compare the effects of FMT in the FMT-treated group vs the placebo group, to see if FMT promotes remission of Chronic diarrhea. Furthermore, researchers will be able to gain insights into whether 2 initial doses are superior to one.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants \\> 18 years\n* Fulfilling and previously diagnosed with SSc according to the 2013 American College of Rheumatology/European League against rheumatisms SSs classification criteria\\[23\\] by rheumatologist or dermatologist.\n* Chronic diarrea is defined as loose or watery stools, three or more times a day, a minimum of 50% of the days within the last four weeks.\n\nExclusion Criteria:\n\n* Inability to understand Danish spoken or written and/or Trial procedures.\n* Known or anticipated pregnancy (excluded by male sex, postmenopausal women, or otherwise negative U-HCG)\n* Previous treatment with FMT\n* Treatment with antibiotics within the past 6 weeks\n* Changes in morphine treatment within the past 4 weeks\n* Ongoing infection with Clostridioides difficile (negative PCR test)\n* Known serious gastrointestinal disease or GI infection (diagnosed with e.g. inflammatory bowel disease and/or gastrointestinal cancer)\n* Dysregulated thyroid disease (TSH) blood sample from previous consultations maximum 6 months old from\n* Known intestinal stricture\n* Planned MR scan within the study period\n* Pacemaker/ICD\n* Previous abdominal surgery (minor surgical procedures ex. appendectomy is allowed)\n* Changes in medicine that affect the GI tract within the past four weeks.\n* Known Severe end-organ disease\n\n * Lung disease with forced vital capacity(FVC)\\<50% and/or diffusing lung capacity for carbon monoxide (DLCO) \\<40%\n * Severe heart failure with ejection fraction \\<30%\n * End-stage kidney disease with glomeration rate\\<30ml/min'}, 'identificationModule': {'nctId': 'NCT06333795', 'acronym': 'FaeMiCue', 'briefTitle': 'Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis - a Randomized, Double-blinded, Safety and Pilot-efficacy Study', 'orgStudyIdInfo': {'id': '1-10-72-131-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Active treatment', 'description': 'Active capsule FMT-treatment', 'interventionNames': ['Procedure: Faecal Microbiota Transplantation (FMT)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo capsules are given.', 'interventionNames': ['Procedure: Placebo']}], 'interventions': [{'name': 'Faecal Microbiota Transplantation (FMT)', 'type': 'PROCEDURE', 'description': 'Treatment is given as capsules.', 'armGroupLabels': ['Active treatment']}, {'name': 'Placebo', 'type': 'PROCEDURE', 'description': 'Treatment is given as capsules.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University Hospital', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'centralContacts': [{'name': 'Nanna S Rolighed, PhD-student', 'role': 'CONTACT', 'email': 'Nanna.rolighed@clin.au.dk', 'phone': '52199715'}, {'name': 'Klaus Krogh, MD, DMSc', 'role': 'CONTACT', 'email': 'klaukrog@rm.dk', 'phone': '23385937'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, DMSc, PhD, Professor', 'investigatorFullName': 'Klaus Krogh', 'investigatorAffiliation': 'University of Aarhus'}}}}