NCT07402226Recruiting
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
Source: ClinicalTrials.gov · Last updated 1 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 21 Jan 2026
- Start date
- 16 Mar 2026
- Primary completion date
- Apr 2027
- Lead sponsor
- University of Michigan
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT07402226
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 16 Mar 2026 to the primary completion date, Apr 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Use of systemic antibiotics within 4 weeks prior to baseline.
Other illness
- 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.
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Michigan Coordinator of this site? Confirm its status | Ann Arbor | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.