protocolSection identificationModule nctId: NCT06333795, orgStudyIdInfo id: 1-10-72-131-23, briefTitle: Faecal Microbiota Transplantation Against Chronic Diarrhea in Patients With Systemic Sclerosis, acronym: FaeMiCue, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: University of Aarhus, class: OTHER, 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., conditionsModule conditions: Diarrhea, conditions: Systemic Sclerosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, 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., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: The study is blinded throughout the active study period, both the patient and investigator are blinded., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Faecal Microbiota Transplantation (FMT), interventions name: Placebo, 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)., secondaryOutcomes measure: Patient-reported treatment outcome on symptoms, secondaryOutcomes measure: Patient-reported measures from the schedule of side effects and telephone call 1 week after each intervention., secondaryOutcomes measure: Patient-reported outcomes from questionnaires., secondaryOutcomes measure: Patient-reported outcomes from questionnaires., secondaryOutcomes measure: Patient-reported outcomes from questionnaires., secondaryOutcomes measure: Patient-reported overall symptom burden, secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the wireless motility capsule., secondaryOutcomes measure: Objective measures from the low-dose CT scan., secondaryOutcomes measure: Breath Test, secondaryOutcomes measure: Faecal microbiota composition, secondaryOutcomes measure: Faecal-calprotectin, secondaryOutcomes measure: Blood plasma proteomics, secondaryOutcomes measure: Blood plasma Fibrosis markers, secondaryOutcomes measure: Blood parameters, secondaryOutcomes measure: Health-related Quality of life, secondaryOutcomes measure: Patient perception of FMT treatment satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Aarhus University Hospital, city: Aarhus, country: Denmark, geoPoint lat: 56.15674, lon: 10.21076, hasResults: False