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
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
Treatments tested in this trial
- Diet 1: Restriction of fermentable carbohydrates
- Diet 2: Elimination of foods harmful to gut barrier and microbiome
- Diet 3: Regular meal patterns, soluble fiber, and portion control
Treatment groups
60 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov