NCT03687814 Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
| NCT ID | NCT03687814 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Michigan |
| Condition | Irritable Bowel Syndrome Characterized by Constipation |
| Study Type | INTERVENTIONAL |
| Enrollment | 78 participants |
| Start Date | 2018-11-08 |
| Primary Completion | 2026-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 78 participants in total. It began in 2018-11-08 with a primary completion date of 2026-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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 days of run-in * Have cognitive dysfunction or unable to understand or provide written informed consent * Pregnancy (evaluated by self-report) * Comorbid medical problems that may affect gastrointestinal transit or motility: * Inflammatory bowel disease * Extra-intestinal disease known to affect the gastrointestinal system (i.e., scleroderma, unstable thyroid disease, etc.) * Severe renal or hepatic disease * Previous abdominal surgery other than appendectomy, cholecystectomy, and gynecologic/urologic surgery if performed more than six months prior to enrollment * Previous treatment with the low FODMAP diet under a dietician guidance * Concurrent medications not permitted including probiotics, antibiotics, prescription or over-the-counter medication for IBS, and narcotics * New antidepressant use (less than 3 months on stable dose) * Active participation in another form of dietary therapy
Contact & Investigator
Stacy B Menees, MD, MS
PRINCIPAL INVESTIGATOR
University of Michigan
Frequently Asked Questions
Who can join the NCT03687814 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Irritable Bowel Syndrome Characterized by Constipation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03687814 currently recruiting?
Yes, NCT03687814 is actively recruiting participants. Contact the research team at sbartnik@med.umich.edu for enrollment information.
Where is the NCT03687814 trial being conducted?
This trial is being conducted at Ann Arbor, United States.
Who is sponsoring the NCT03687814 clinical trial?
NCT03687814 is sponsored by University of Michigan. The principal investigator is Stacy B Menees, MD, MS at University of Michigan. The trial plans to enroll 78 participants.