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Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation

NCT03687814 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-03-04

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome Characterized by Constipation

Interventions

OTHER

Low 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.

OTHER

sham 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.

Sponsors & Collaborators

Principal Investigators

  • Stacy B Menees, MD, MS · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-08
Primary Completion
2026-01-31
Completion
2026-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03687814 on ClinicalTrials.gov