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NCT07402226

Systemic Sclerosis DIet for GastrointESTinal Symptoms

Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~60 participants
Updated 2026-07-01 on ClinicalTrials.gov
What's tested:Diet 1: Restriction of fermentable carbohydratesDiet 2: Elimination of foods harmful to gut barrier and microbiomeDiet 3: Regular meal patterns, soluble fiber, and portion control

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Bloating severity
Measured over Baseline to week 6

Conditions

Systemic Sclerosis (SSc)

Explore related trials

Systemic Scleroderma

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

  • Dinesh Khanna, MD, MSc · PRINCIPAL_INVESTIGATOR · University of Michigan

Who to contact

Rosemary Gedert
[email protected]
734-764-6466
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria
Willingness and ability to comply with dietary intervention and study procedures.
Ability to provide informed consent.

Exclusion

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

What this trial measures

  • Change in Bloating severityBaseline to week 6

    As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.1 - Gastrointestinal Gas and Bloating 13a - 13 questions with raw summed scores ranging from 13-36.