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Stool and urine markers to track diet changes in irritable bowel syndrome

Tests whether stool or urine markers can track diet in irritable bowel syndrome.

Key facts

Who runs it
University of Michigan
Where
Ann Arbor, United StatesSee the site
Trial code
Registry title
Defining Objective Markers of Compliance for Dietary Therapies in IBS
Status
Recruiting
People taking part
94 people, planned
Started
11 May 2026
Expected to end
Dec 2027
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Diet A - elimination diet
  • Diet B - healthy eating diet
Record updated
22 June 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with irritable bowel syndrome (IBS) to test whether a stool or urine marker can track changes in carbohydrate intake during a diet study.

Age
18-65 years at screening
Sex
All sexes
Disease stage
IBS of the diarrhea, mixed or constipation type, with an IBS-SSS symptom score of at least 175. Warning signs such as rectal bleeding, weight loss, night pain or night diarrhea are allowed only if checked since they began with normal results (colonoscopy, fecal calprotectin or CRP).
Earlier treatment
No special diet such as low-fat, low FODMAP or gluten-free in the past 6 months. No oral antibiotics in the past 3 months. People with lactose intolerance can join and keep limiting lactose.

Main reasons for not taking part

  • Celiac disease, inflammatory bowel disease or microscopic colitis
  • Eating disorder needing treatment in the past 10 years, or BMI < 18.5
  • Past small bowel or colon surgery (other than appendectomy or cholecystectomy), or appendectomy or cholecystectomy in the last 6 months
  • Planned changes to IBS medicines, diet, exercise or other therapies during the study
  • Pregnant or breastfeeding

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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 prior small bowel or colonic surgery (other than appendectomy or cholecystectomy)
  • Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study
  • 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
  • History of appendectomy or cholecystectomy in the last 6 months
  • BMI < 18.5
  • Oral antibiotic use in the past 3 months
  • Currently pregnant or breastfeeding

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 65 years old?

Where in United States

  • University of MichiganAnn Arbor, United StatesContact: Prashant Singh, MBBSTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Diet A - elimination dietTreatment being tested
  • Diet B - healthy eating dietExisting treatment, for comparison

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial
Plain-language title
Stool and urine markers to track diet changes in irritable bowel syndromeGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07494968, who can take part
Record updated
22 June 2026