Not Yet RecruitingNot Applicable

Defining Objective Markers of Compliance for Dietary Therapies in IBS

United States94 participantsStarted 2026-04

Plain-language summary

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 participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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

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

What they're measuring

Correlation between fecal GIP excretion and fructo-oligosaccharide intake

Timeframe: Week 4

Trial details

NCT IDNCT07494968

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-12

Contact for this trial

Prashant Singh, MBBS

734-647-9252 singhpr@umich.edu

View on ClinicalTrials.gov More Irritable Bowel Syndrome trials