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
University of Michigan
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.
Description
The rationale for keeping the diets (arms/interventions names) vague is it prevents other researchers from using these diets in their studies, minimizes expectation bias of patients (who can have preference for one diet over other) and prevents participants from trying other diets before end of study period in case they don't respond.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 gastroin…
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.
Location
- University of MichiganAnn Arbor, Michigan