🔎 Trials Near Me

Home › Scleroderma › NCT07402226

Systemic Sclerosis DIet for GastrointESTinal Symptoms

Recruiting

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

Who can join

Ages 18 and older · All sexes

Full 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

About the study

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.

What is being tested

Sponsor: University of Michigan · Participants: 60 · Started: Mar 16, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07402226

Locations in the U.S.

MichiganUniversity of Michigan, Ann Arbor

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.