Diet approaches for gastrointestinal symptoms in systemic sclerosis

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 project will test whether three different diets reduce bloating and other gastrointestinal symptoms in people with systemic sclerosis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Michigan (Academic / other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT07402226 on ClinicalTrials.gov

What this trial studies

Adults with systemic sclerosis who report moderate to severe bloating will be assigned to one of three dietary approaches: restriction of fermentable carbohydrates, elimination of foods thought to harm the gut barrier and microbiome, or regular meal patterns with soluble fiber and portion control. Researchers will compare changes in bloating/distention, abdominal pain, and overall gastrointestinal symptom burden using validated measures such as the UCLA SCTC-GIT 2.0. Key exclusions include inflammatory bowel disease, celiac disease, recent systemic antibiotics, recent significant gastrointestinal surgery, and significant cognitive or psychiatric impairment. The trial is conducted at the University of Michigan with dietary details provided to participants and follow-up visits to monitor adherence and symptoms.

Who should consider this trial

Good fit: People diagnosed with systemic sclerosis by ACR/EULAR criteria who report moderate to severe bloating (UCLA SCTC-GIT 2.0 bloating score ≥2) and who can follow dietary instructions and provide informed consent.

Not a fit: Patients with inflammatory bowel disease, celiac disease, recent antibiotic use, recent major gastrointestinal surgery, severe cognitive or psychiatric impairment, or dietary allergies that prevent participation may not benefit or be eligible.

Why it matters

Potential benefit: If successful, a specific dietary approach could reduce bloating and abdominal pain and improve daily functioning for people with systemic sclerosis.

How similar studies have performed: Dietary approaches like low-FODMAP have helped people with irritable bowel syndrome, but rigorous data specifically in systemic sclerosis are limited, so this application is relatively novel.

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

Where this trial is running

Ann Arbor, Michigan

• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Dinesh Khanna, MD, MSc — University of Michigan
• Study coordinator: Rosemary Gedert

Conditions Systemic Sclerosis