Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT07402226

Systemic Sclerosis DIet for GastrointESTinal Symptoms

Led by University of Michigan · Updated on 2026-03-24

60

Participants Needed

1

Research Sites

54 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Systemic Sclerosis DIet for GastrointESTinal Symptoms

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of systemic sclerosis (SSc) according to ACR/EULAR criteria
  • Moderate to severe gastrointestinal bloating or distension with a UCLA SCTC-GIT 2.0 bloating score of 2.00 or higher at screening
  • Willingness and ability to follow the dietary intervention and study procedures
  • Ability to provide informed consent
Not Eligible

You will not qualify if you...

  • Diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis) or celiac disease
  • Use of systemic antibiotics within 4 weeks before baseline
  • History of gastrointestinal surgery except cholecystectomy or appendectomy unless within the last 3 months
  • Severe cognitive or psychiatric illness limiting ability to follow diet instructions
  • Known allergy or intolerance to major diet components unless manageable within diet
  • Current or recent (within 3 months) dietary intervention for gastrointestinal symptoms
  • Significant self-reported weight loss (10% or more) in last 3 months
  • Body mass index (BMI) less than 20
  • Ongoing tube feeding or total parenteral nutrition (TPN)
  • Participation in another interventional trial
  • Pregnancy, lactation, or planning pregnancy in the next 6 months

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

University of Michigan

Ann Arbor, Michigan, United States, 48109

Actively Recruiting

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Research Team

R

Rosemary Gedert

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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