Low FODMAP diet and PEG 3350 for treating constipation in IBS patients

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

This study is testing if a low FODMAP diet combined with a laxative can help people with constipation from Irritable Bowel Syndrome feel better.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 78 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Michigan (Academic / other)
• Locations: 1 site (Ann Arbor, Michigan)
• Trial ID: NCT03687814 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of a low FODMAP diet combined with PEG 3350 in patients suffering from Irritable Bowel Syndrome characterized by constipation (IBS-C). Participants will be randomly assigned to receive either the low FODMAP diet with PEG 3350 or a sham diet with PEG 3350, with the goal of comparing improvements in abdominal symptoms, quality of life, and constipation-related complaints. The study will utilize a blinded approach for both participants and data analysts to ensure unbiased results. The trial is being conducted at the University of Michigan Health System, focusing on a specific patient population with IBS-C.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who meet the Rome IV criteria for IBS-C.

Not a fit: Patients with other subtypes of IBS or those with significant comorbid conditions affecting gastrointestinal function may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new dietary approach to significantly alleviate symptoms for patients with IBS-C.

How similar studies have performed: While low FODMAP diets have shown promise in treating IBS-D, this approach for IBS-C is relatively novel and has not been extensively tested.

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

Where this trial is running

Ann Arbor, Michigan

• University of Michigan — Ann Arbor, Michigan, United States (Recruiting)

Study contacts

• Principal investigator: Stacy B Menees, MD, MS — University of Michigan
• Study coordinator: Stacy Menees, MD, MS

Conditions Irritable Bowel Syndrome Characterized by Constipation