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NCT01091805 · ClinicalTrials.gov registry record
Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux
A clinical trial, sponsored by Wake Forest University Health Sciences.
- Completed
- Registry status
- 143
- Enrollment target
NCT01091805: Completed study, sponsored by Wake Forest University Health Sciences.
NCT01091805 is a clinical trial that has completed, run by Wake Forest University Health Sciences. The registered enrollment target is 143 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01091805 has completed, sponsored by Wake Forest University Health Sciences.
- COMPLETED
- Registry status
- 143 participants
- Enrollment target
Study Summary
The purpose of this research study is to see if GE reflux events are associated with increasing levels of pepsin in spit samples. Pepsin is a special protein called an "enzyme" that is made only in your stomach. It is not normally found in your throat. Pepsin breaks down food proteins that you eat to form nutritional building blocks that your body can use to grow. An enzyme is a substance that helps break down proteins. Gastroesophageal reflux disease (GERD) is very common in infants and children, but can result in serious health problems if not accurately diagnosed. The investigators currently do not have a definitive test to be used as a standard for diagnosing pediatric GERD. Measurement of pepsin, an enzyme normally produced only in the stomach, has been used as a non-invasive way to detect gastric aspiration (reflux of stomach fluid into the airway) in both adults and children, but using pepsin to detect reflux has not been tested. Since pepsin should not be present in the normal esophagus and respiratory tract, but is always present in reflux fluid from the stomach, the investigators believe that the more GE reflux the investigators detect, the higher the levels of pepsin the investigators see in the fluid collected from the mouth. If patients do not have GE reflux, but have swallowing problems alone in which food or liquid goes into the airway, the investigators expect that these patients will have no pepsin in the fluid collected from their mouth. The investigators will test these hypotheses by measuring pepsin levels from mouth fluid and comparing them with the number of GE reflux events the investigators find using the pH/impedance (MII (multichannel intraluminal impedance)) test. Since the investigators are interested in pepsin levels for all types of reflux - acid and non-acid -the investigators will study children whether or not they are on acid blocking medicines. The investigators will also look at pepsin levels in patients whose pH/MII is normal,
Primary Outcome
1. Total number of GE reflux events by MII over 24 hours. Events will be further subdivided into acid or non-acid based on distal pH measurements. 2. Total number of GE reflux events by MII over 24 hours will be classified as distal, mid, or proximal esophagus. Proximal events will be classified as acid or non-acid based on proximal pH sensor recordings. 3. Esophageal clearance time for all GE reflux events. 4. Oropharyngeal pepsin concentration immediately before and 30 minutes after feeds. 5.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 143 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-10 |
What the finished NCT01091805 record still lists
NCT01091805 is an observational study that tracks outcomes without assigning an intervention. The registered 143 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT01091805 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01091805 about?
NCT01091805 is a clinical study titled "Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux". The purpose of this research study is to see if GE reflux events are associated with increasing levels of pepsin in spit samples. Pepsin is a special protein called an "enzyme" that is made only in your stomach. It is not normally found in your throat. Pepsin breaks down food proteins that you eat t...
What is the current status of trial NCT01091805?
This trial is currently completed. The enrollment target is 143 participants. The study started on 2008-12. Estimated completion is 2013-10.
Who is sponsoring clinical trial NCT01091805?
This trial is sponsored by Wake Forest University Health Sciences, which has 1,140 total clinical trials registered on ClinicalTrials.gov.
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