Recruiting

Dietary Intervention

Sponsor:

University of Michigan

Code:

NCT07402226

Conditions

Systemic Sclerosis (SSc)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Diet 1: Restriction of fermentable carbohydrates

Diet 2: Elimination of foods harmful to gut barrier and microbiome

Diet 3: Regular meal patterns, soluble fiber, and portion control

Study Details

Brief 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.

Conditions

Systemic Sclerosis (SSc)

Study ID

NCT07402226

Start date

Mar 16, 2026

Status verified date

Jun, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Diet 1: Restriction of fermentable carbohydrates

experimental: Diet 2: Elimination of foods harmful to gut barrier and microbiome

experimental: Diet 3: Regular meal patterns, soluble fiber, and portion control

Interventions

Diet 1: Restriction of fermentable carbohydrates

6 weeks guided diet under the supervision of a dietician restricting fermentable carbohydrates known to trigger GI symptoms.

Diet 2: Elimination of foods harmful to gut barrier and microbiome

6 weeks guided diet under the supervision of a dietician eliminating of foods harmful to gut barrier and microbiome

Diet 3: Regular meal patterns, soluble fiber, and portion control

6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control.

Primary outcome measure

  • Change in Bloating severity [ Time Frame: Baseline to week 6 ]

Central Contacts and Locations

Central contacts

Rosemary Gedert

734-764-6466ssc-digest@med.umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Rosemary Gedert

734-764-6466ssc-digest@med.umich.edu

Principal Investigator:

Dinesh Khanna, MD, MSc

More Information

Sponsor

University of Michigan

Last update posted

Jul 1, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-07-01.