Who is eligible for clinical trial NCT07494968?

Participants must meet protocol criteria for Irritable Bowel Syndrome. Confirm exact inclusion and exclusion requirements with the study coordinator.

Does clinical trial NCT07494968 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-06-18

Defining Objective Markers of Compliance for Dietary Therapies in IBS (NCT07494968)

🟢 Recruiting Observational / Diagnostic 🧠 Behavioral & Psychological Program Sponsor: University of Michigan

🩺 Plain-English Summary (8th-Grade Level)

This research will investigate if a specific marker in your stool or urine can be used to track changes in your carbohydrate intake including fructo-oligosaccharide and mannitol intake

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (3 items) and avoid the listed exclusions (11 items).

Location: University of Michigan — Ann Arbor, Michigan

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Patients with IBS ( including diarrhea, mixed or constipation type) and without unexplained alarm features (rectal bleeding, weight loss, nocturnal pain, nocturnal diarrhea). In presence of alarm symptoms, if they have had evaluation with colonoscopy or fecal calprotectin or serum C-reactive protein (CRP) since onset of alarm symptoms with normal results, they will be included.
Aged 18-65 years at the time of screening
IBS-SSS of at least 175 at baseline

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Subjects adhering to a dietary treatment such as the low-fat diet, low FODMAP diet, or gluten-free diet, within the past 6 months. Those who are lactose intolerant will not be excluded from the study and will be allowed to limit lactose intake as previously.
Subjects who are predicted to make changes to their baseline IBS medication(s), over-the-counter (OTC) therapy, exercise, diet (beyond what is advised), or initiate/make changes to other complementary therapy that could affect IBS symptoms (e.g. yoga, acupuncture, etc.) during the four weeks study period.
Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
BMI \< 18.5
Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).
History of appendectomy or cholecystectomy in the last 6 months.
Oral antibiotic use in the past 3 months
Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
Currently pregnant or breastfeeding.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of Michigan — Ann Arbor, Michigan

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

🏛️ View Official NIH Record ↗