Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux (Pepsin)
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ClinicalTrials.gov Identifier: NCT01091805 |
Recruitment Status
:
Completed
First Posted
: March 24, 2010
Last Update Posted
: April 13, 2017
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Tracking Information | |||
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First Submitted Date | March 23, 2010 | ||
First Posted Date | March 24, 2010 | ||
Last Update Posted Date | April 13, 2017 | ||
Actual Study Start Date | December 2008 | ||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | ||
Change History | Complete list of historical versions of study NCT01091805 on ClinicalTrials.gov Archive Site | ||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | ||
Current Other Outcome Measures | Not Provided | ||
Original Other Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title | Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux | ||
Official Title | Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux | ||
Brief 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, but have aspiration alone that the investigators find on a modified barium swallow (MBS) study. The investigators will measure pepsin levels in healthy children with no reflux symptoms and no swallowing problems as the investigators controls. The investigators anticipate that this study will show a positive correlation between GE reflux events and the presence of oropharyngeal pepsin, which may allow us to use pepsin as a way to test for reflux. |
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Detailed Description | Not Provided | ||
Study Type | Observational | ||
Study Design | Observational Model: Case-Only Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||
Biospecimen | Not Provided | ||
Sampling Method | Non-Probability Sample | ||
Study Population | Wake Forest University Baptist Medical Center, Section of Gastroenterology Pediatric Clinic | ||
Condition | Gastroesophageal Reflux Disease (GERD) | ||
Intervention | Not Provided | ||
Study Groups/Cohorts | Not Provided | ||
Publications * | Fortunato JE, D'Agostino RB Jr, Lively MO. Pepsin in saliva as a biomarker for oropharyngeal reflux compared with 24-hour esophageal impedance/pH monitoring in pediatric patients. Neurogastroenterol Motil. 2017 Feb;29(2). doi: 10.1111/nmo.12936. Epub 2016 Sep 7. | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status | Completed | ||
Actual Enrollment |
143 | ||
Original Estimated Enrollment |
170 | ||
Actual Study Completion Date | October 2013 | ||
Actual Primary Completion Date | September 2013 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | ||
Accepts Healthy Volunteers | Yes | ||
Contacts | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries | United States | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number | NCT01091805 | ||
Other Study ID Numbers | IRB00006309 | ||
Has Data Monitoring Committee | No | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement | Not Provided | ||
Responsible Party | Wake Forest University Health Sciences | ||
Study Sponsor | Wake Forest University Health Sciences | ||
Collaborators | Takeda | ||
Investigators | Not Provided | ||
PRS Account | Wake Forest University Health Sciences | ||
Verification Date | March 2013 |