RecruitingNot ApplicableNCT07402226

Systemic Sclerosis DIet for GastrointESTinal Symptoms

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


Sponsor

University of Michigan

Enrollment

60 participants

Start Date

Mar 16, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether specific dietary changes can reduce bloating, abdominal pain, and other gut symptoms in people with systemic sclerosis (SSc), an autoimmune disease that can cause significant digestive problems. Participants will be randomly assigned to one of three different diets, and the study is intentionally keeping the diet names vague to avoid bias. Adults with a confirmed diagnosis of SSc who report moderate to severe bloating or distension may be eligible, while people with inflammatory bowel disease, celiac disease, recent antibiotic use, or pregnancy are excluded. Participation involves following the assigned diet and completing surveys about symptoms over the study period. This summary was generated with AI assistance to help patients understand the study in plain language.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALDiet 1: Restriction of fermentable carbohydrates

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

BEHAVIORALDiet 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

BEHAVIORALDiet 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.


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT07402226


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