NCT07494968 Defining Objective Markers of Compliance for Dietary Therapies in IBS
| NCT ID | NCT07494968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Irritable Bowel Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2026-05-11 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2026-05-11 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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.
Contact & Investigator
Prashant Singh, MBBS
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT07494968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Irritable Bowel Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07494968 currently recruiting?
Yes, NCT07494968 is actively recruiting participants. Contact the research team at singhpr@umich.edu for enrollment information.
Where is the NCT07494968 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT07494968 clinical trial?
NCT07494968 is sponsored by University of Michigan. The principal investigator is Prashant Singh, MBBS at University of Michigan. The trial plans to enroll 94 participants.