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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
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
Inclusion Criteria: * Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria .• 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. * Willingness and ability to comply with dietary intervention and study procedures. * Ability to provide informed consent. Exclusion Criteria: * Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease. * Use of systemic antibiotics within 4 weeks prior to baseline. * History of gastrointestinal surgery (other than cholecystectomy or appendectomy unless in the last 3 months). * Severe cognitive impairment or psychiatric illness that would limit ability to follow dietary instructions. * Known allergy or intolerance to major components of any of the study diets (e.g., lactose, gluten) unless manageable within diet framework. * Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.). * Clinically significant self-reported (≥10 percent weight loss) in the last 3 months * BMI less than 20 * Ongoing tube feeds or TPN * Participating in another interventional trial * Pregnancy or lactation, or planning pregnancy in the next 6 months
About the study
This research will evaluate the effect of diets on bloating/distention, 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.
What is being tested
- Diet 1: Restriction of fermentable carbohydrates (behavioral)
- Diet 2: Elimination of foods harmful to gut barrier and microbiome (behavioral)
- Diet 3: Regular meal patterns, soluble fiber, and portion control (behavioral)
Sponsor: University of Michigan · Participants: 60 · Started: Mar 16, 2026
Contact the study team
- Rosemary Gedert · Phone: 734-764-6466
Official record on ClinicalTrials.gov — NCT07402226
Locations in the U.S.
| Michigan | University of Michigan, Ann Arbor |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.