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Defining Objective Markers of Compliance for Dietary Therapies in IBS

NCT07494968 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2026-03-27

No results posted yet for this study

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

Conditions

  • Irritable Bowel Syndrome

Interventions

BEHAVIORAL

Diet A - elimination diet

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.

BEHAVIORAL

Diet B - healthy eating diet

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

Sponsors & Collaborators

Principal Investigators

  • Prashant Singh, MBBS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-30
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07494968 on ClinicalTrials.gov