Systemic Sclerosis DIet for GastrointESTinal Symptoms (DIGEST)

University of Michigan

Status: Not yet enrolling

Conditions: Systemic Sclerosis (SSc)

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

Study type: Interventional

Funder types: Other

Identifiers

NCT07402226

HUM00285136

Details and patient eligibility

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Diet 1: Restriction of fermentable carbohydrates

Experimental group

Treatment:

Behavioral: Diet 1: Restriction of fermentable carbohydrates

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

Experimental group

Treatment:

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

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

Experimental group

Treatment:

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