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NCT03687814 · ClinicalTrials.gov registry record · NA
Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation
A NA study of Irritable Bowel Syndrome Characterized by Constipation, sponsored by University of Michigan.
- Recruiting
- Registry status
- NA
- Development phase
- 78
- Enrollment target
- 1
- Study location
NCT03687814: Recruiting NA study of Irritable Bowel Syndrome Characterized by Constipation, sponsored by University of Michigan.
NCT03687814 is a NA study of Irritable Bowel Syndrome Characterized by Constipation that is actively recruiting participants, run by University of Michigan. The registered enrollment target is 78 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03687814, a NA study of Irritable Bowel Syndrome Characterized by Constipation, is actively recruiting participants, sponsored by University of Michigan.
- RECRUITING
- Registry status
- NA
- Development phase
- 78 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- OTHER Low FODMAP diet/PEG 3350
- OTHER sham diet/PEG 3350
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 78 participants |
| Start Date | 2018-11-08 |
| Est. Completion | 2026-01 |
| Phase | NA |
What NCT03687814 shows while recruiting
NCT03687814 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 78 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Irritable Bowel Syndrome Characterized by Constipation appearing as the primary indexed condition, and to 2 interventions - of which Low FODMAP diet/PEG 3350 is the first listed.
NCT03687814 reports a single indexed study location in Michigan.
Frequently Asked Questions
What is clinical trial NCT03687814 about?
NCT03687814 is a clinical study titled "Low FODMAP Plus PEG 3350 for the Treatment of Patients with Irritable Bowel Syndrome-Constipation". 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...
What is the current status of trial NCT03687814?
This trial is currently recruiting. It is a NA study. The enrollment target is 78 participants. The study started on 2018-11-08. Estimated completion is 2026-01.
What conditions does trial NCT03687814 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome Characterized by Constipation.
What interventions are being tested in trial NCT03687814?
The interventions under investigation include: Low FODMAP diet/PEG 3350 (OTHER), sham diet/PEG 3350 (OTHER).
Who is sponsoring clinical trial NCT03687814?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03687814 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03687814's enrollment target sits among peer trials
78 1060th of 2000 higher than 939 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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