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NCT06004596 · ClinicalTrials.gov registry record · NA
Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)
A NA study of Gastroparesis, sponsored by Cairn Diagnostics.
- Completed
- Registry status
- NA
- Development phase
- 182
- Enrollment target
- 3
- Study locations
NCT06004596: Completed NA study of Gastroparesis, sponsored by Cairn Diagnostics.
NCT06004596 is a NA study of Gastroparesis that has completed, run by Cairn Diagnostics. The registered enrollment target is 182 participants, below the 298-participant average among 44 other Gastroparesis trials with a reported enrollment target (39% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06004596, a NA study of Gastroparesis, has completed, sponsored by Cairn Diagnostics.
- COMPLETED
- Registry status
- NA
- Development phase
- 182 participants
- Enrollment target
- 3
- Study locations
Study Summary
The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose children that are suspected of having a condition called gastroparesis, which means that food doesn't empty from their stomach normally. Participants will blow into test tubes to collect breath samples before and after eating a scrambled egg GEBT meal that contains a small amount of specially grown Spirulina (a blue-green alga used as a dietary supplement) that contains mostly carbon-13 (a non-radioactive kind of carbon atom). Analysis of the amount of 13C in the carbon dioxide in breath before and after eating the GEBT meal can measure how fast food is emptying from the stomach.
Primary Outcome
13CO2 excretion rate calculated at 15 minutes after meal completion
Conditions Studied
Interventions
- DIAGNOSTIC_TEST 13C-Spirulina Gastric Emptying Breath Test (GEBT)
- DIAGNOSTIC_TEST 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat
Study Locations (3)
Tennessee
- Cairn Diagnostics - Brentwood
Texas
- Texas Children's Hospital/Baylor College of Medicine - Houston
Wisconsin
- Medical College of Wisconsin - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 182 participants |
| Start Date | 2023-03-17 |
| Est. Completion | 2024-09-30 |
| Phase | NA |
What the finished NCT06004596 record still lists
NCT06004596 is an interventional study that assigns participants to a tested intervention. The registered 182 participants enrollment target is mid-sized for trials with a published cap, below the 298-participant average among 44 other Gastroparesis trials with a reported enrollment target (39% lower).
The record links to 1 condition, with Gastroparesis appearing as the primary indexed condition, and to 2 interventions - of which 13C-Spirulina Gastric Emptying Breath Test (GEBT) is the first listed.
NCT06004596 reports a single indexed study location in Tennessee, Texas, Wisconsin.
Frequently Asked Questions
What is clinical trial NCT06004596 about?
NCT06004596 is a clinical study titled "Establishing a Pediatric Reference Range for the 13C-Spirulina Gastric Emptying Breath Test (GEBT)". The goal of this clinical trial is to define the normal response to the 13C-Spirulina Gastric Emptying Breath Test (GEBT) in children, so that we can use this test to help diagnose children that are suspected of having a condition called gastroparesis, which means that food doesn't empty from their ...
What is the current status of trial NCT06004596?
This trial is currently completed. It is a NA study. The enrollment target is 182 participants. The study started on 2023-03-17. Estimated completion is 2024-09-30.
What conditions does trial NCT06004596 study?
This clinical trial studies the following conditions: Gastroparesis.
What interventions are being tested in trial NCT06004596?
The interventions under investigation include: 13C-Spirulina Gastric Emptying Breath Test (GEBT) (DIAGNOSTIC_TEST), 13C-Spirulina Gastric Emptying Breath Test (GEBT) - repeat (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT06004596?
This trial is sponsored by Cairn Diagnostics, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06004596 being conducted?
This trial has 3 study locations across Tennessee, Texas, Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT06004596's enrollment target sits among peer trials
182 13th of 44 higher than 32 of 44 other Gastroparesis trials
participants (enrollment target), bucketed by value
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