Irritable Bowel Syndrome (IBS) Clinical Trials

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

Who is this study for? Patients with Irritable Bowel Syndrome, Constipation
What treatments are being studied? Low FODMAP Diet/PEG 3350
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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:

• related to defecation

• associated with a change in the frequency of stool (reduction of stools)

• 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

Locations
United States
Michigan
University of Michigan
RECRUITING
Ann Arbor
Contact Information
Primary
Stacy Menees, MD, MS
sbartnik@med.umich.edu
734-232-3739
Backup
Amy Liu, BS
liuyalie@med.umich.edu
734-647-4794
Time Frame
Start Date: 2018-11-08
Estimated Completion Date: 2026-01
Participants
Target number of participants: 78
Treatments
Experimental: Low FODMAP diet plus PEG 3350
Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax).
Sham_comparator: Sham diet plus PEG 3350
Subjects will follow a sham diet and will take PEG 3350 (Miralax).
Related Therapeutic Areas
Sponsors
Leads: University of Michigan

This content was sourced from clinicaltrials.gov