Recruiting

Carbohydrate Tracking

Sponsor:

University of Michigan

Code:

NCT07494968

Conditions

Irritable Bowel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Diet A - elimination diet

Diet B - healthy eating diet

Study Details

Brief 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

Study ID

NCT07494968

Start date

May 11, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

94 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Diet A - elimination diet

active comparator: Diet B - healthy eating diet

Interventions

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.

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Prashant Singh, MBBS

734-647-9252singhpr@umich.edu

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Principal Investigator:

Prashant Singh, MBBS

More Information

Sponsor

University of Michigan

Last update posted

Jun 22, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2026-06-22.