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Low FODMAP Diet Plus PEG 3350 for Irritable Bowel Syndrome with Constipation (IBS-C)

This study is looking at new ways to treat Irritable Bowel Syndrome with Constipation (IBS-C). Researchers want to see if a low FODMAP diet (a diet that limits certain types of carbohydrates) combined with PEG 3350 (Miralax) works better than PEG 3350 with a sham diet (a diet that seems like an intervention but doesn't change FODMAPs). You might be able to join if you are 18 or older and have IBS-C, which means you have recurring abdominal pain and changes in your bowel habits. The main goal is to see if the low FODMAP diet group has more improvement in abdominal pain after 3-4 weeks. The study plans to enroll 78 participants, but its current status is unclear.

Study design
This is an interventional study comparing two groups: one receiving a low FODMAP diet plus PEG 3350, and another receiving a sham diet plus PEG 3350. It plans to enroll 78 participants.
What's involved
Participants will follow a specific diet and take PEG 3350 daily for 4 weeks. The study will measure improvement in abdominal pain during weeks 3 and 4.
Compensation
Not stated in the trial record.
Follow-up
Improvement in abdominal pain is measured during weeks 3 and 4 of the 4-week treatment period.

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NCT03687814

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

Recruiting
NAAges 18+InterventionalTreatment
University of Michigan
~78 participants
Updated 2025-03-04 on ClinicalTrials.gov
What's tested:Low FODMAP diet/PEG 3350sham diet/PEG 3350

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Improvement of abdominal pain as measured by 11-point numerical rating scale
Measured over during weeks 3 and 4

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Explore related trials

Irritable Bowel Syndrome

Where it's being run

1 sites across 1 states
Michigan1

Study leadership

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

Who to contact

Stacy Menees, MD, MS
[email protected]
734-232-3739
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

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

What this trial measures

  • Improvement of abdominal pain as measured by 11-point numerical rating scaleduring weeks 3 and 4

    Compare the proportion of patients with IBS-C on a diet of low FODMAP diet plus PEG 3350 vs. sham diet plus PEG 3350 reporting an improvement of abdominal pain. It is defined 30% reduction in abdominal pain during weeks 3 \& 4 of each diet compared with baseline using an 11-point numerical rating scale (NRS) (0-no pain, 11-intolerable pain). Appropriate between-group statistical comparisons will be conducted.