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New treatment option for Systemic Sclerosis (SSc)
Official title Systemic Sclerosis DIet for GastrointESTinal Symptoms
ClinicalTrials.gov ID: NCT07402226
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of systemic sclerosis (SSc) as per ACR/EULAR classification criteria . Self-reported moderate to severe gastrointestinal bloating or...
- Willingness and ability to comply with dietary intervention and study procedures.
- Ability to provide informed consent.
You likely can't join if
- 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.).
See the full eligibility 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...
- Willingness and ability to comply with dietary intervention and study procedures.
- Ability to provide informed consent.
- 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 treatment trial
- Pregnancy or lactation, or planning pregnancy in the next 6 months
The study team makes the final eligibility decision.
Where it's taking place
- Ann Arbor, Michigan, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ann Arbor, Michigan, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.