Defining Objective Markers of Compliance for Dietary Therapies in IBS
Defining Objective Markers of Compliance for Dietary Therapies in Irritable Bowel Syndrome (IBS) Using a Randomized Controlled Trial
University of Michigan
94 participants
May 11, 2026
INTERVENTIONAL
Conditions
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
Eligibility
Inclusion Criteria3
- 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
Exclusion Criteria10
- 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 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.
- BMI < 18.5
- Subjects with prior small bowel or colonic surgery (other than appendectomy or cholecystectomy).
- History of appendectomy or cholecystectomy in the last 6 months.
- Oral antibiotic use in the past 3 months
- Any planned significant changes in dietary or exercise regimen within 30 days prior to Screening or during the study.
- Currently pregnant or breastfeeding.
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Interventions
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.
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
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07494968