NCT07402226

Systemic Sclerosis DIet for GastrointESTinal Symptoms

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Systemic Sclerosis (SSc)

Interventions

Type	Name	Description
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.
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
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.

Timeline

• Start date: 2026-03-16
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-02-11
• Last updated: 2026-03-24

Locations

1 site across 1 country: United States