Diet approaches for gastrointestinal symptoms in systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Dinesh Khanna, MD, MSc — University of Michigan
• Study coordinator: Rosemary Gedert
• Email: ssc-digest@med.umich.edu
• Phone: 734-764-6466

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.