protocolSection identificationModule nctId: NCT06268990, orgStudyIdInfo id: FE 1159/6-1, briefTitle: FMT in Obesity: RYGB vs. LEAN vs. Autologous FMT, acronym: DACH, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-21, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Wiebke Kristin Fenske, class: OTHER, collaborators name: Medical University of Graz, descriptionModule briefSummary: This double-blinded proof-of-concept study is proposed to explore the effects of fecal microbiota transfer (FMT) in human subjects. Here we perform FMTs into obese recipients using stool from lean unoperated donors and from previously obese patients after successfull treatment with bariatric Roux-en-Y Gastric Bypass (RYGB) surgery. Obese patients treated with their own material (autologous FMT) serve as controls. After FMT treatment the functional impact of post-surgery microbiome changes on host energy consumption and regulation of blood glucose levels will be analysed. Additionally the variations on the microbiota and metabolite composition will be profiled using extensive sequencing analyses. The major aim of the study is to explore the scientific rationale for targeted gut microbiota modulation in management of obesity and related metabolic diseases.We estimate the transfer of microbiota from RYGB donors is superior to the transfer of lean microbiota at inducing reduced adiposity and improving high blood glucose levels in obese recipients. Each is better than a sham procedure (autologous FMT), which itself can also induce considerable short-term effects., conditionsModule conditions: Morbid Obesity, conditions: Metabolic Syndrome, conditions: Diabetes, conditions: PreDiabetes, conditions: Insulin Resistance, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Fecal microbiota transplantation, outcomesModule primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Glucose homeostasis, secondaryOutcomes measure: Body weight, secondaryOutcomes measure: Blood pressure, secondaryOutcomes measure: Fasting lipid profile, secondaryOutcomes measure: Fasting blood liver enzyme levels, secondaryOutcomes measure: Dietary intake levels, secondaryOutcomes measure: Metabolic inflammation, secondaryOutcomes measure: Gut hormones, secondaryOutcomes measure: Hunger and Satiety Scores, secondaryOutcomes measure: Fecal microbiota composition, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Tolerability of repeated FMT, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Department of Internal Medicine, Medical University Graz, status: RECRUITING, city: Graz, zip: 8010, country: Austria, contacts name: Julia K Mader, Assoc. Prof., role: CONTACT, phone: +43 316 38582383, email: julia.mader@medunigraz.at, contacts name: Julia K Mader, Assoc. Prof., role: PRINCIPAL_INVESTIGATOR, contacts name: Patrizia Kump, PD Dr, role: SUB_INVESTIGATOR, geoPoint lat: 47.06667, lon: 15.45, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-05-14, uploadDate: 2024-01-29T10:24, filename: Prot_SAP_000.pdf, size: 651727, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2023-09-15, uploadDate: 2024-02-16T08:19, filename: ICF_001.pdf, size: 276426, hasResults: False