Systemic Sclerosis DIet for GastrointESTinal Symptoms

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07402226
Status
Recruiting
Apply to this trial

Conditions

  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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 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 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.

Study Details

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.

Key Dates

Start date
Mar 16, 2026
Status verified
Mar 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Change in Bloating severity [ Time Frame: Baseline to week 6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Rosemary Gedert
[email protected]
734-764-6466
Dinesh Khanna, MD, MSc (PRINCIPAL_INVESTIGATOR)

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University of Michigan· Ann Arbor, MI

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