Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
Part of paid clinical trials in Ann Arbor, Michigan.
- Sponsor
- University of Michigan
- Study ID
- NCT03687814
- Status
- Recruiting
Conditions
- Irritable Bowel Syndrome Characterized by Constipation
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Low FODMAP diet/PEG 3350 — OTHERSubjects will follow a low FODMAP diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
- sham diet/PEG 3350 — OTHERSubjects will follow a sham diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
Study Details
Consecutive patients with Irritable Bowel Syndrome with Constipation (IBS-C) will be recruited from the outpatient clinics of the University of Michigan Health System. Eligible patients will be asked to participate in a study that will test the efficacy the PEG 3350 + a diet low in fermentable oligo, di, monosaccharides, and polyols (FODMAP) vs. PEG 3350 plus sham diet. Blinding dietary advice trials is challenging and therefore the sham diet was based on the criteria set forth by Staudacher et al. which emphasizes that the diet must give the impression that is the true intervention diet with similar restrictions, modifications, and time intensity without impacting the intake of essential nutrients, fiber, and FODMAPs. An example of the sham diet's carbohydrates includes: apples, bananas, and pears, and wheat. Oranges, raspberries, strawberries and rice would not be allowed. Additionally, the physicians analyzing the data will be blinded as to which group the patients were randomized.
Key Dates
- Start date
- Nov 8, 2018
- Status verified
- Feb 2025
- Primary completion
- Jan 31, 2026
- Completion
- Jan 31, 2026
Study Design
- Enrollment
- 78 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Low FODMAP diet plus PEG 3350Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).
- Sham Comparator: Sham diet plus PEG 3350Subjects will follow a sham diet and will take PEG 3350 (Miralax).
Primary Outcome Measure
Improvement of abdominal pain as measured by 11-point numerical rating scale [ Time Frame: during weeks 3 and 4 ]
Central Contacts
- Stacy Menees, MD, MS734-232-3739
- Amy Liu, BS734-647-4794
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | Stacy Menees, MD |