[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100579721":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":58,"collaborators":11,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":65,"acronym":11,"eligibilityCriteria":66,"healthyVolunteers":63,"sex":67,"minAge":68,"maxAge":11,"enrollmentInfo":69,"targetDuration":11,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"The University of Texas Health Science Center, Houston","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PRIM-DJ2727","EXPERIMENTAL",null,[13],"Drug: PRIM-DJ2727",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo","PLACEBO_COMPARATOR",[18],"Drug: Placebo",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":11},"DRUG","For oral administration, each dose will contain the number of capsules needed to deliver the lyophilized intestinal bacteria powder derived after lyophilization of 60 g of filtered stool in 300 mL 0.85% NaCl and 2% mannitol. Participants will take the capsules (5-6 capsules twice weekly) from week 2 through week 10. Capsules will be taken over a period of up to one hour to maximize tolerance and ensure the capsules are not expelled by vomiting.\n\nFor administration via retention enema, which will be done at baseline and week 11, 50 g of filtered, frozen stool in 250 mL of 0.85% sodium chloride (NaCl) will be used.",[9],{"type":21,"name":15,"description":25,"armGroupLabels":26,"otherNames":11},"Placebo will be administered as capsules from week 2-10 and as enema at baseline and week 11.",[15],[28],{"name":29,"affiliation":5,"role":30},"Zsuzsanna McMahan, MD, MHS","PRINCIPAL_INVESTIGATOR",[32,36],{"name":29,"role":33,"phone":34,"phoneExt":11,"email":35},"CONTACT","713-500-7531","Zsuzsanna.H.McMahan@uth.tmc.edu",{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},"Ashish P Balar, MBBS, MPH","713-500-4409","Ashish.P.Balar@uth.tmc.edu",[41],{"facility":42,"status":43,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The University of Texas Health Science Center at Houston","RECRUITING","Houston","Texas","77030","United States","US",{"type":50,"coordinates":51},"Point",[52,53],-95.36327,29.76328,{"lat":53,"lon":52},[56,57],{"name":29,"role":33,"phone":34,"phoneExt":11,"email":35},{"name":37,"role":33,"phone":38,"phoneExt":11,"email":39},{"type":30,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Zsuzsanna Hortobagyi Mcmahan","Associate Professor of Medicine, Co-Director of the UTHealth Scleroderma Center","100579721","phase-2-a-study-of-microbiome-transplantation-for-the-treatment-of-constipation-andor-significant-bloating-in-patients-with-systemic-sclerosis-100579721",false,"NCT06827977","A Study of Microbiome Transplantation for the Treatment of Constipation and\u002For Significant Bloating in Patients With Systemic Sclerosis","Inclusion Criteria:\n\n* Are seen in the UT Houston Scleroderma Center (UTHSC)\n* Meet 2013 American college of rheumatology (ACR)\u002FEuropean league against rheumatism (EULAR) criteria or CREST criteria for SSc\n* Meet Rome IV criteria for constipation and\u002For significant bloating\n* Subject willing to sign an informed consent form\n* Subject deemed likely to survive for ≥ 1 year after enrollment\n* Able to follow study procedure and follow-up\n* Sexually active male and female subjects of childbearing potential must agree to use an effective method of birth control during the treatment and follow-up period\n* Female subjects of childbearing potential must have a negative pregnancy test in the 72 hours before the procedure\n* Subjects who agree to adhere to a stable diet for at least 4 weeks before joining the study and throughout the study\n* Subjects must have an attending physician who will provide non-transplant care for the subject\n\nExclusion Criteria:\n\n* Subjects with constipation and\u002For significant bloating from causes not attributed to SSc as determined by the treating physician (e.g., inflammatory bowel disease, medication, significant diabetes, or hypothyroidism, etc.)\n* Subjects unwilling to stop taking probiotic supplements during the duration of the study\n* Subjects that have post-total or hemicolectomy or the presence of a colostomy\n* Subjects unable to tolerate microbiome transplant via enema for any reason or swallow capsules\n* Subjects requiring systemic antibiotic therapy 4 weeks before the study\n* If subjects are on immunosuppression, the immunosuppression dose should be stable for at least 4 weeks before study enrollment","ALL","18 Years",{"count":70,"type":71},21,"ESTIMATED","INTERVENTIONAL",[74],"PHASE2","The purpose of this study is to characterize the intestinal flora in subjects with systemic sclerosis-related constipation and\u002For significant bloating and to determine safety and trends in improvements in the diversity of colonic microbiome and patient symptoms following the administration of either frozen or lyophilized PRIM-DJ2727 microbiota.",[77,78],"Constipation","Bloating",[80],"Systemic Sclerosis","2025-06-21",{"date":83,"type":84},"2025-06-26","ACTUAL",{"date":86,"type":84},"2025-03-03",{"date":88,"type":71},"2026-09-26",{"name":5,"class":6},1]