Actively Recruiting
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
Led by University of Michigan · Updated on 2025-03-04
78
Participants Needed
1
Research Sites
373 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 and older
- Meet Rome IV criteria for IBS-C with recurrent abdominal pain at least 1 day per week in the last 3 months
- Abdominal pain associated with at least two of the following: related to defecation, change in stool frequency (reduction), change in stool form (hard or lumpy stools)
- More than 25% hard stools and less than 25% loose stools
- Criteria fulfilled for the last 3 months
You will not qualify if you...
- IBS subtype other than IBS-C
- More than 3 spontaneous bowel movements during the last 7 days before the study run-in
- Cognitive dysfunction or inability to understand or provide written informed consent
- Pregnancy
- Medical conditions affecting gastrointestinal transit or motility such as inflammatory bowel disease, scleroderma, unstable thyroid disease
- Severe kidney or liver disease
- Previous abdominal surgery except appendectomy, cholecystectomy, or gynecologic/urologic surgery performed more than six months prior
- Prior treatment with low FODMAP diet under dietician guidance
- Use of probiotics, antibiotics, prescription or over-the-counter IBS medications, narcotics
- New antidepressant use less than 3 months on a stable dose
- Active participation in another dietary therapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
Research Team
S
Stacy Menees, MD, MS
CONTACT
A
Amy Liu, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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