RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2018-11-08
Study Completion:2025-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03687814

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Subjects aged 18 and older meeting the Rome IV criteria for IBS-C\*:
  2. 1. related to defecation
  3. 2. associated with a change in the frequency of stool (reduction of stools)
  4. 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
  1. * any other IBS subtype other than IBS-C
  2. * \>3 spontaneous bowel movements during the last 7 days of run-in
  3. * Have cognitive dysfunction or unable to understand or provide written informed consent
  4. * Pregnancy (evaluated by self-report)
  5. * Comorbid medical problems that may affect gastrointestinal transit or motility:
  6. * Inflammatory bowel disease
  7. * Extra-intestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.)
  8. * Severe renal or hepatic disease
  9. * Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery if performed more than six months prior to enrollment
  10. * Previous treatment with the low FODMAP diet under a dietician guidance
  11. * Concurrent medications not permitted including probiotics, antibiotics, prescription or over-the-counter medication for IBS, and narcotics
  12. * New antidepressant use (less than 3 months on stable dose)
  13. * Active participation in another form of dietary therapy

Contacts and Locations

Study Contact

Stacy Menees, MD, MS
CONTACT
734-232-3739
sbartnik@med.umich.edu
Amy Liu, BS
CONTACT
734-647-4794
liuyalie@med.umich.edu

Principal Investigator

Stacy B Menees, MD, MS
PRINCIPAL_INVESTIGATOR
University of Michigan

Study Locations (Sites)

University of Michigan
Ann Arbor, Michigan, 48109
United States

Collaborators and Investigators

Sponsor: University of Michigan

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-11-08
Study Completion Date2025-01

Study Record Updates

Study Start Date2018-11-08
Study Completion Date2025-01

Terms related to this study

Additional Relevant MeSH Terms

  • Irritable Bowel Syndrome Characterized by Constipation