Gastroesophageal Reflux Disease (GERD)PepsinNCT01091805
Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux
An observational study of Gastroesophageal Reflux Disease (GERD), run by Wake Forest University Health Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- How many people
- 143 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Oct 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Wake Forest University Baptist Medical Center, Section of Gastroenterology Pediatric Clinic
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Wake Forest University Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
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.
Read more
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.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Medical subject headings
- Gastroesophageal Reflux
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive correlation between GE reflux events and oropharyngeal pepsin concentrations
- 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.
Measured: 24 Hours
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.
Measured: 24 hours
Secondary outcomes (2)
Non-acid GE reflux events are positively correlated with increasing levels of oropharyngeal pepsin.
- 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.
Measured: 24 hours
Patients with isolated oral aspiration (without GE reflux) will have no oropharyngeal pepsin.
- 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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startDec 2008
- Primary completionSep 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Takeda
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091805
- Sponsor's protocol ID
- IRB00006309
- Acronym
- Pepsin
- Status last verified
- Mar 2013
- First submitted
- 23 Mar 2010
- Last updated
- 13 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 27604397
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Oropharyngeal Pepsin and Gastroesophageal (GE) Reflux
- ClinicalTrials.gov ID
- NCT01091805
- Acronym / sponsor ID
- Pepsin / IRB00006309
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- Takeda
- Study start
- Dec 2008 (actual)
- Primary completion
- Sep 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Wake Forest University Baptist Medical Center, Section of Gastroenterology Pediatric Clinic
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive correlation between GE reflux events and oropharyngeal pepsin concentrations
Time frame: 24 Hours
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. 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
2 secondary outcomes
Non-acid GE reflux events are positively correlated with increasing levels of oropharyngeal pepsin.
Time frame: 24 hours
Patients with isolated oral aspiration (without GE reflux) will have no oropharyngeal pepsin.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2017.
- Derived from this study: PubMed 27604397Fortunato 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroesophageal Reflux Disease (GERD), run by Wake Forest University Health Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive correlation between GE reflux events and oropharyngeal pepsin concentrations (time frame: 24 Hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091805, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2017.