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NCT04054349 · ClinicalTrials.gov registry record · NA
The Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders
A NA study of Autism Spectrum Disorder, sponsored by Ohio State University.
- Completed
- Registry status
- NA
- Development phase
- 15
- Enrollment target
- 1
- Study location
NCT04054349: Completed NA study of Autism Spectrum Disorder, sponsored by Ohio State University.
NCT04054349 is a NA study of Autism Spectrum Disorder that has completed, run by Ohio State University. The registered enrollment target is 15 participants, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04054349, a NA study of Autism Spectrum Disorder, has completed, sponsored by Ohio State University.
- COMPLETED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
- 1
- Study location
Study Summary
This study assesses the effect of the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet on gastrointestinal (GI) and behavioral problems in children with autism spectrum disorder (ASD). The objectives of this study are: -To determine whether the low FODMAP diet causes a decrease in gastrointestinal problems related to ASD -To determine whether the low FODMAP diet causes a decrease in behavioral problems -To assess the effect of decreased gastrointestinal problems on reduction of behavioral problems
Primary Outcome
Before the study period and at the end of the two weeks, the effect of the low FODMAP diet on the severity of GI disorders was assessed with the Pediatric Quality of Life Inventory (PedsQL) Gastrointestinal Module-Parent Report. A 74-item survey with 14 scales items: stomach pain and hurt (6 items), discomfort when eating (5), food and drink limits (6), trouble swallowing (3), heartburn/reflux (4), nausea/vomiting (4), gas and bloating (7), constipation (14), blood in poop (2), diarrhea (7), wor
Conditions Studied
Interventions
- OTHER Low FODMAP diet
Study Locations (1)
Ohio
- The Ohio State University Nisonger Center - Columbus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2019-01-03 |
| Est. Completion | 2019-07-30 |
| Phase | NA |
What the finished NCT04054349 record still lists
NCT04054349 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 135-participant average among 224 other Autism Spectrum Disorder trials with a reported enrollment target (89% lower).
The record links to 1 condition, with Autism Spectrum Disorder appearing as the primary indexed condition, and to 1 intervention - of which Low FODMAP diet is the first listed.
NCT04054349 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT04054349 about?
NCT04054349 is a clinical study titled "The Effect of the Low Fodmap Diet in Children With Autism Spectrum Disorders". This study assesses the effect of the low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet on gastrointestinal (GI) and behavioral problems in children with autism spectrum disorder (ASD). The objectives of this study are: -To determine whether the low FODMAP d...
What is the current status of trial NCT04054349?
This trial is currently completed. It is a NA study. The enrollment target is 15 participants. The study started on 2019-01-03. Estimated completion is 2019-07-30.
What conditions does trial NCT04054349 study?
This clinical trial studies the following conditions: Autism Spectrum Disorder.
What interventions are being tested in trial NCT04054349?
The interventions under investigation include: Low FODMAP diet (OTHER).
Who is sponsoring clinical trial NCT04054349?
This trial is sponsored by Ohio State University, which has 552 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04054349 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04054349's enrollment target sits among peer trials
15 209th of 224 higher than 14 of 224 other Autism Spectrum Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Autism Spectrum Disorder 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.
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