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NCT03052439 · ClinicalTrials.gov registry record · NA
Diet Reintroduction Study in Irritable Bowel Syndrome
A NA study of Irritable Bowel Syndrome, sponsored by University of Michigan.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT03052439 is a NA study of Irritable Bowel Syndrome that has completed, run by University of Michigan. The registered enrollment target is 20 participants, below the 144-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT03052439, a NA study of Irritable Bowel Syndrome, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of the US population and up to 20% of the population worldwide. This is a condition that is diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as the exclusion of select other GI diseases. IBS not only causes constipation, diarrhea, abdominal cramping, and bloating, it also significantly affects quality of life, overall functioning, and work productivity. The cause of IBS is likely multifactorial, which makes it a difficult disease to treat. However, patients often associate their IBS symptoms with eating a meal. Up to 90% of IBS patients restrict their diet to prevent or improve their symptoms, and patients are increasingly interested in more holistic approaches to disease management. At present, the most persuasive evidence that dietary changes can treat IBS supports a diet low in fermentable carbohydrates (the low FODMAP (fermentable oligo, di, and monosaccharides and polyols) diet). This diet, which is low in certain carbohydrates, has been shown to improve IBS symptoms (particularly abdominal pain and bloating), but can be difficult to follow and quite restrictive. In addition, this diet is not meant to be used as a maintenance diet; patients undergo an elimination phase followed by a reintroduction phase of specific carbohydrate groups as they monitor their symptoms. From the results of our proposed study, the study team hopes to arrive at a modified, less -restrictive version of the low FODMAP diet that is equally effective, and also create a standard protocol that patients can use during this reintroduction phase. Patients with IBS will be recruited into a 13-week trial that would help determine the optimal way in which high FODMAP foods should be introduced. After consent, patients would start on a low FODMAP diet for 14 days, and if their symptoms improve, they would be invited to continue in the study. For 7 days prior to the r
Conditions Studied
Interventions
- OTHER FODMAP
Study Locations (1)
Michigan
- University of Michigan - Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2017-07-05 |
| Est. Completion | 2020-04-22 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03052439
The ClinicalTrials.gov registry entry for NCT03052439 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 144-participant average among 47 other Irritable Bowel Syndrome trials with a reported enrollment target (86% lower). The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Irritable Bowel Syndrome appearing as the primary indexed condition, and to 1 intervention - of which FODMAP is the first listed.
NCT03052439 reports 1 study location spanning 1 distinct geographic area - top geographies include Michigan.
Frequently Asked Questions
What is clinical trial NCT03052439 about?
NCT03052439 is a clinical study titled "Diet Reintroduction Study in Irritable Bowel Syndrome". Irritable bowel syndrome (IBS) is the most common gastrointestinal disease, affecting 12% of the US population and up to 20% of the population worldwide. This is a condition that is diagnosed based on specific symptoms of altered bowel habits and abdominal pain, as well as the exclusion of select ot...
What is the current status of trial NCT03052439?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2017-07-05. Estimated completion is 2020-04-22.
What conditions does trial NCT03052439 study?
This clinical trial studies the following conditions: Irritable Bowel Syndrome.
What interventions are being tested in trial NCT03052439?
The interventions under investigation include: FODMAP (OTHER).
Who is sponsoring clinical trial NCT03052439?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03052439 being conducted?
This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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