[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623868":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":60,"collaborators":11,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":65,"sex":71,"minAge":72,"maxAge":11,"enrollmentInfo":73,"targetDuration":11,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":11,"overallStatus":45,"whyStopped":11,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"Diet 1: Restriction of fermentable carbohydrates","EXPERIMENTAL",null,[13],"Behavioral: Diet 1: Restriction of fermentable carbohydrates",{"label":15,"type":10,"description":11,"interventionNames":16},"Diet 2: Elimination of foods harmful to gut barrier and microbiome",[17],"Behavioral: Diet 2: Elimination of foods harmful to gut barrier and microbiome",{"label":19,"type":10,"description":11,"interventionNames":20},"Diet 3: Regular meal patterns, soluble fiber, and portion control",[21],"Behavioral: Diet 3: Regular meal patterns, soluble fiber, and portion control",[23,27,30],{"type":24,"name":9,"description":25,"armGroupLabels":26,"otherNames":11},"BEHAVIORAL","6 weeks guided diet under the supervision of a dietician restricting fermentable carbohydrates known to trigger GI symptoms.",[9],{"type":24,"name":15,"description":28,"armGroupLabels":29,"otherNames":11},"6 weeks guided diet under the supervision of a dietician eliminating of foods harmful to gut barrier and microbiome",[15],{"type":24,"name":19,"description":31,"armGroupLabels":32,"otherNames":11},"6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control.",[19],[34],{"name":35,"affiliation":5,"role":36},"Dinesh Khanna, MD, MSc","PRINCIPAL_INVESTIGATOR",[38],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},"Rosemary Gedert","CONTACT","734-764-6466","ssc-digest@med.umich.edu",[44],{"facility":5,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"RECRUITING","Ann Arbor","Michigan","48109","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-83.74088,42.27756,{"lat":55,"lon":54},[58,59],{"name":39,"role":40,"phone":41,"phoneExt":11,"email":42},{"name":35,"role":36,"phone":11,"phoneExt":11,"email":11},{"type":36,"investigatorFullName":61,"investigatorTitle":62,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Dinesh Khanna, MD, MS","Frederick G L Huetwell Professor of Rheumatology, Professor of Internal Medicine and Program Director, Internal Medicine, Medical School","100623868","systemic-sclerosis-diet-for-gastrointestinal-symptoms-100623868",false,"NCT07402226","Systemic Sclerosis DIet for GastrointESTinal Symptoms","SSc-DIGEST Trial: Systemic Sclerosis DIet for GastrointESTinal Symptoms Randomized Controlled Trial of Low FODMAP, CDED, and NICE Diets for Gastrointestinal Symptoms in Systemic Sclerosis","DIGEST","Inclusion Criteria:\n\n* Diagnosis of systemic sclerosis (SSc) as per ACR\u002FEULAR classification criteria\n\n  .• Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score ≥2.00 on (0.00-3.00 scale) at screening.\n* Willingness and ability to comply with dietary intervention and study procedures.\n* Ability to provide informed consent.\n\nExclusion Criteria:\n\n* Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease.\n* Use of systemic antibiotics within 4 weeks prior to baseline.\n* History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months).\n* Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions.\n* Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework.\n* Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.).\n* Clinically significant self-reported (≥10 percent weight loss) in the last 3 months\n* BMI less than 20\n* Ongoing tube feeds or TPN\n* Participating in another interventional trial\n* Pregnancy or lactation, or planning pregnancy in the next 6 months","ALL","18 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78],"NA","This research will evaluate the effect of diets on bloating\u002Fdistention, assess changes in abdominal pain, and overall gastrointestinal symptom burden in Systemic Sclerosis. The researchers will do this by comparing outcomes of people assigned to 3 different diets. Following the research specifics of the diets will be available upon contact with the details listed below.",[81],"Systemic Sclerosis (SSc)","2026-06-30",{"date":84,"type":85},"2026-07-01","ACTUAL",{"date":87,"type":85},"2026-03-16",{"date":89,"type":75},"2027-04",{"name":5,"class":6},1]