Dietary Interventions for Systemic Sclerosis

(DIGEST Trial)

Overseen By Rosemary Gedert

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Dinesh Khanna, MD, MSc

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for individuals with Systemic Sclerosis experiencing gastrointestinal symptoms. Specific eligibility criteria are not provided, but typically participants must meet certain health conditions to be included.

Inclusion Criteria

Willingness and ability to comply with dietary intervention and study procedures

I have been diagnosed with systemic sclerosis.

Ability to provide informed consent

Exclusion Criteria

Current or recent (within 3 months) dietary intervention for managing GI symptoms (e.g. gluten-free diet, low FODMAP diet, etc.)

Participating in another interventional trial

I haven't taken antibiotics in the last 4 weeks.

What Are the Treatments Tested in This Trial?

Interventions

• Systemic Sclerosis Diet

Trial Overview

The study compares the effects of three different diets on gastrointestinal symptoms in Systemic Sclerosis patients: one eliminates harmful foods, another restricts fermentable carbs, and a third focuses on regular meals with soluble fiber.

How Is the Trial Designed?

Group I: Diet 3: Regular meal patterns, soluble fiber, and portion control Experimental Treatment 1 Intervention

Group II: Diet 2: Elimination of foods harmful to gut barrier and microbiome Experimental Treatment 1 Intervention

Group III: Diet 1: Restriction of fermentable carbohydrates Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+