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โ† Trials
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Systemic Sclerosis DIet for GastrointESTinal Symptoms

RecruitingNAAges 18 Years - anyAllUniversity of Michigan
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria .โ€ข Self-reported moderate to severe gastrointestinal bloating or distension, with a UCLA SCTC-GIT 2.0 bloating Scale score โ‰ฅ2.00 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 (โ‰ฅ10 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
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What it tests

  • 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
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Where

1 site
University of Michigan
Ann Arbor, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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