Systemic Sclerosis DIet for GastrointESTinal Symptoms

Official title

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

Overview

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.

Interventions

• 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.

Primary outcome measures

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

Secondary outcome measures (3)

• Change in Bloating severity [Time frame: Baseline to week 6]
• Change in Abdominal pain severity [Time frame: Baseline to week 6]
• Change in Overall GI symptom [Time frame: Baseline to week 6]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• University of Michigan — Ann Arbor

Identifiers

NCT: NCT07402226 · HUM00285136

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗