Comparing 3 diets for stomach and bowel symptoms in systemic sclerosis
Compares 3 diets for bloating and belly pain in adults with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: Systemic Sclerosis DIet for GastrointESTinal Symptoms
Key facts
- Where
- Ann Arbor, United StatesSee the site
Where in United States
- University of MichiganAnn Arbor, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Michigan
- Trial code
- NCT07402226
- Record updated
- 1 July 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: Use of systemic antibiotics within 4 weeks prior to baseline; Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease; 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.