Health TrialsbyHealthPanel

Systemic Sclerosis DIet for GastrointESTinal Symptoms

ConditionSystemic Sclerosis (SSc)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Michigan

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria

Willingness and ability to comply with dietary intervention and study procedures.

Ability to provide informed consent.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Diet 1: Restriction of fermentable carbohydratesExperimental treatment 1 intervention
Group B: Diet 2: Elimination of foods harmful to gut barrier and microbiomeExperimental treatment 1 intervention
Group C: Diet 3: Regular meal patterns, soluble fiber, and portion controlExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Bloating severity

As assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Scale v1.1 - Gastrointestinal Gas and Bloating 13a - 13 questions with raw summed scores ranging from 13-36.

Time frame
Baseline to week 6

Secondary outcomes

1

Change in Bloating severity

As assessed by the UCLA Scleroderma Clinical Trial Consortium Gastrointestinal Tract (UCLA SCTC GIT 2.0). The bloating score is a subsection of 4 questions with 4 options each. The score ranges from .0-3 where higher numbers indicate more frequent bloating.

Time frame
Baseline to week 6
2

Change in Abdominal pain severity

As assessed by the PROMIS Scale v1.0 - Gastrointestinal Belly Pain 5a - 5 questions with raw summed score range of 6-25.

Time frame
Baseline to week 6
3

Change in Overall GI symptom

UCLA SCTC GIT 2.0 total score (all sections but constipation) with a range of (0-2.83). Higher scores indicate more severe symtoms.

Time frame
Baseline to week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Michigan

Lead sponsor

Source ClinicalTrials.gov
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