Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux (Pepsin)

Tracking Information
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; (submitted: March 23, 2010)	Positive correlation between GE reflux events and oropharyngeal pepsin concentrations [ Time Frame: 24 Hours ] 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. 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. Esophageal clearance time for all GE reflux events. Oropharyngeal pepsin concentration immediately before and 30 minutes after feeds. Oropharyngeal pepsin concentration after awakening.; Compare oropharyngeal pepsin concentrations in patients with GE reflux to a. patients with normal pH/MII and isolated oral aspiration on MBS b. healthy controls. [ Time Frame: 24 hours ]
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; (submitted: March 23, 2010)	Non-acid GE reflux events are positively correlated with increasing levels of oropharyngeal pepsin. [ Time Frame: 24 hours ] 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. 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. Esophageal clearance time for all GE reflux events. Oropharyngeal pepsin concentration immediately before and 30 minutes after feeds. Oropharyngeal pepsin concentration after awakening.; Patients with isolated oral aspiration (without GE reflux) will have no oropharyngeal pepsin. [ Time Frame: 24 hours ] 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. 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. Esophageal clearance time for all GE reflux events. Oropharyngeal pepsin concentration immediately before and 30 minutes after feeds. Oropharyngeal pepsin concentration after awakening.
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.
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Case-Only; Time Perspective: Prospective
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.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: April 11, 2017)	143
Original Estimated Enrollment; (submitted: March 23, 2010)	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: Pediatric patients from birth to 18 years (including premature infants) who are deemed clinically to require 24 hour esophageal pH/impedance.; Pediatric patients (newborn to 18 years) undergoing MBS who have had or will have pH/MII monitoring within 6 months.; Patients' parents or legal guardians will provide written informed consent for the protocol. When appropriate, patient assent will be obtained. Exclusion Criteria: Patients with anatomic facial anomalies or facial discomfort precluding nasal intubation of the pH/MII catheter.; Patient unable to complete a 24 hour pH/MII study.; Children fed exclusively with nasogastric or nasojejunal (transpyloric) tube at the time of study.
Sex/Gender	Sexes Eligible for Study: All
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