Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
University of Michigan
Summary
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.
Description
A. Specific Aims: While a diet low in fermentable oligo, di, monosaccharides and polyols (FODMAPs) has gained popularity as a treatment for patients with Irritable Bowel Syndrome and diarrhea (IBS-D), the impact of this diet on patients with IBS and constipation (IBS-C) is unknown. We propose a randomized, controlled trial in IBS-C patients to compare the efficacy of PEG 3350 and the low FODMAP diet to PEG 3350 and a sham diet. We hypothesize that: 1. The PEG 3350 and low FODMAP diet group will achieve greater improvements in abdominal symptoms including pain, discomfort, and bloating than th…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1\. Subjects aged 18 and older meeting the Rome IV criteria for IBS-C\*: • Recurrent abdominal pain, on average, at least 1 day/week in the last 3 months, associated with two or more of the following: 1. related to defecation 2. associated with a change in the frequency of stool (reduction of stools) 3. associated with a change in the form of stool (hard or lumpy stools) AND \>25% hard stools and \<25% loose stools \* Criteria fulfilled for the last 3 months Exclusion Criteria: * any other IBS subtype other than IBS-C * \>3 spontaneous bowel movements during the last 7…
Interventions
- OtherLow FODMAP diet/PEG 3350
Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
- Othersham diet/PEG 3350
Subjects will follow a sham diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
Location
- University of MichiganAnn Arbor, Michigan