Systemic Sclerosis DIet for GastrointESTinal Symptoms

Purpose

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.

Condition

  • Systemic Sclerosis (SSc)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)
Masking Description
Due to the dietary counseling intervention, it will not be possible to blind dietitians and participants. Participants will be aware of general participation in dietary therapy but blinded to specific diet names. Investigators, outcome assessors, and the biostatistician will be fully blinded to allocation.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Diet 1: Restriction of fermentable carbohydrates
  • 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.
Experimental
Diet 2: Elimination of foods harmful to gut barrier and microbiome
  • 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
Experimental
Diet 3: Regular meal patterns, soluble fiber, and portion control
  • 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.

Recruiting Locations

University of Michigan
Ann Arbor, Michigan 48109
Contact:
Rosemary Gedert
734-764-6466
ssc-digest@med.umich.edu

More Details

Status
Recruiting
Sponsor
University of Michigan

Study Contact

Rosemary Gedert
734-764-6466
ssc-digest@med.umich.edu

Detailed 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.