Defining Objective Markers of Dietary Compliance in IBS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study investigates whether an objective biomarker can quantify intake of specific carbohydrates, including fructo-oligosaccharides and mannitol, by comparing Biomarker GIP signal with 24-hour diet recalls at Week 4 in adults with IBS. Participants will follow either an elimination diet or a healthy eating diet to see how the biomarker tracks dietary content. The primary goal is to determine if the biomarker can reliably indicate carbohydrate intake to support dietary treatment decisions. The study is conducted at the University of Michigan and aims to translate dietary adherence assessment into clinical practice.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. 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.
2. Aged 18-65 years at the time of screening
3. IBS-SSS of at least 175 at baseline

Exclusion Criteria:

1. 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.
2. 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.
3. Subjects with a known history of celiac disease, inflammatory bowel disease or microscopic colitis
4. Subjects with a history of an eating disorder requiring medical or behavioral treatment within the past 10 years.
5. BMI \< 18.5
6. Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).
7. History of appendectomy or cholecystectomy in the last 6 months.
8. Oral antibiotic use in the past 3 months
9. Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
10. Currently pregnant or breastfeeding.

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Prashant Singh, MBBS — University of Michigan
• Study coordinator: Prashant Singh, MBBS
• Email: singhpr@umich.edu
• Phone: 734-647-9252

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.