NCT07402226 Systemic Sclerosis DIet for GastrointESTinal Symptoms
| NCT ID | NCT07402226 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Systemic Sclerosis (SSc) |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2026-03-16 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2026-03-16 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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
Contact & Investigator
Dinesh Khanna, MD, MSc
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07402226 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Systemic Sclerosis (SSc). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07402226 currently recruiting?
Yes, NCT07402226 is actively recruiting participants. Contact the research team at ssc-digest@med.umich.edu for enrollment information.
Where is the NCT07402226 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07402226 clinical trial?
NCT07402226 is sponsored by University of Michigan. The principal investigator is Dinesh Khanna, MD, MSc at University of Michigan. The trial plans to enroll 60 participants.