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
University of Michigan
60 participants
Mar 16, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- 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 Criteria11
- 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
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Interventions
6 weeks guided diet under the supervision of a dietician restricting fermentable carbohydrates known to trigger GI symptoms.
6 weeks guided diet under the supervision of a dietician eliminating of foods harmful to gut barrier and microbiome
6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07402226