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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 willing to sign a consent form. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BEHAVIORAL

Diet 1: Restriction of fermentable carbohydrates

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

BEHAVIORAL

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

BEHAVIORAL

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.

Locations (1)

University of Michigan
Ann Arbor, Michigan, United States