Systemic Sclerosis DIet for GastrointESTinal Symptoms

NCT07402226 | Recruiting

• 1 other identifier: HUM00285136
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Sclerosis (SSc)

Outcome Measures

Primary Outcomes (1)

• Change in Bloating severity

  As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.1 - Gastrointestinal Gas and Bloating 13a - 13 questions with raw summed scores ranging from 13-36.

  Baseline to week 6

Secondary Outcomes (3)

• Change in Bloating severity

  Baseline to week 6

• Change in Abdominal pain severity

  Baseline to week 6

• Change in Overall GI symptom

  Baseline to week 6

Study Arms (3)

Diet 1: Restriction of fermentable carbohydrates

EXPERIMENTAL

Behavioral: Diet 1: Restriction of fermentable carbohydrates

Diet 2: Elimination of foods harmful to gut barrier and microbiome

EXPERIMENTAL

Behavioral: Diet 2: Elimination of foods harmful to gut barrier and microbiome

Diet 3: Regular meal patterns, soluble fiber, and portion control

EXPERIMENTAL

Behavioral: Diet 3: Regular meal patterns, soluble fiber, and portion control

Interventions

Diet 1: Restriction of fermentable carbohydrates BEHAVIORAL

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

Diet 1: Restriction of fermentable carbohydrates

Diet 2: Elimination of foods harmful to gut barrier and microbiome BEHAVIORAL

6 weeks guided diet under the supervision of a dietician eliminating of foods harmful to gut barrier and microbiome

Diet 2: Elimination of foods harmful to gut barrier and microbiome

Diet 3: Regular meal patterns, soluble fiber, and portion control BEHAVIORAL

6 weeks guided diet under the supervision of a dietician emphasizing regular meal patterns, soluble fiber, and portion control.

Diet 3: Regular meal patterns, soluble fiber, and portion control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Microbiota

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Microbiological Phenomena; Biota; Biodiversity; Ecosystem; Environment; Ecological and Environmental Phenomena; Biological Phenomena; Environment and Public Health

Study Officials

• Dinesh Khanna, MD, MSc

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosemary Gedert

CONTACT

734-764-6466; ssc-digest@med.umich.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Frederick G L Huetwell Professor of Rheumatology, Professor of Internal Medicine and Program Director, Internal Medicine, Medical School

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: February 11, 2026
• Study Start: March 16, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)