Defining Objective Markers of Compliance for Dietary Therapies in IBS

Part of paid clinical trials in Ann Arbor, Michigan.

Sponsor
University of Michigan
Study ID
NCT07494968
Status
Not Yet Recruiting

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Conditions

  • Irritable Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Diet A - elimination diet — BEHAVIORAL
    Combined oligosaccharide intake (fructans plus galacto-oligosaccharides) will be limited to \<0.50 grams per serving (same as above), while polyols, lactose, and fructose will not be limited.
  • Diet B - healthy eating diet — BEHAVIORAL
    The subjects will be instructed to regularly eat 3 meals and 3 snacks a day, never too much or too little each time, never to be hungry or too full; to eat in peace and quiet and to chew thoroughly; drinks at least 8 cups of fluids a day, reduce intake of fatty or spicy foods, coffee, alcohol; avoid soft drinks and carbonated beverages, chewing gums, and sweeteners that ends with -ol, and to eat fibers with focus on soluble fibers such as oats but distribute the intake evenly during the day

Study Details

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

Key Dates

Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
94 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Diet A - elimination diet
  • Active Comparator: Diet B - healthy eating diet

Primary Outcome Measure

Correlation between fecal GIP excretion and fructo-oligosaccharide intake [ Time Frame: Week 4 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of MichiganAnn ArborMichigan48109
Prashant Singh, MBBS
[email protected]
734-647-9252
Prashant Singh, MBBS (PRINCIPAL_INVESTIGATOR)
Allen Lee, MD, MS (SUB_INVESTIGATOR)

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