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Pepsin As A Biomarker For Aspiration

Pepsin as a Biomarker for Aspiration Due to Gastroesophageal Reflux

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00865995
Enrollment
76
Registered
2009-03-20
Start date
2008-02-29
Completion date
2012-12-31
Last updated
2013-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aspiration, Gastroesophageal Reflux

Keywords

pepsin, aspiration, GE reflux

Brief summary

Evaluation of tracheal pepsin as a biomarker for aspiration

Detailed description

Aspiration is well recognized in children who have chronic lung disease or who are intubated. There is a known association between gastroesophageal reflux (GER) and aspiration. The distinction between aspiration of swallowed material, such as food and the aspiration of refluxed gastric contents is important. Determining whether an aspiration syndrome in an individual is due to GER may be difficult. The most widely used test to determine whether GER is the cause of aspiration involves staining bronchoalveolar lavage (BAL) fluid for lipid laden macrophages (LLM) based on the hypothesis that refluxed and aspirated fluid is phagocytosed by tracheal macrophages. Pepsinogen is a protein unique to gastric chief cells and also requires acidic conditions for activation. Therefore the presence of pepsin in BAL fluid should only be found when gastric fluid is aspirated. In previous studies, pepsin has been detected in the tracheal fluid of children with chronic lung disease. Thus far, studies of this material have been small, not all have control groups, and LLM were not looked for in all studies. Based on previous studies and the need to improve diagnostic methods, the following aims are proposed: 1. to determine the frequency of pepsin contamination of children without chronic respiratory disease undergoing elective surgery with intubation 2. to determine frequency of tracheal pepsin and lipid laden macrophages (LLM) in children with chronic respiratory disease or symptoms and in children with tracheostomies 3. to compare the presence or absence and concentration of pepsin to the presence of LLM 4. to relate the presence or absence and concentration of pepsin to clinical status To achieve these aims, BAL fluid will be obtained from subject patients and controls. These fluids will be transported to the research lab and stored on ice until analysis. Determination of LLM will be done in children undergoing diagnostic bronchoscopy in the clinical lab of CHW per routine. BAL analysis will consist of Western blot staining for the presence of pepsin. Demographic data will also be collected from the medical record.

Interventions

PROCEDURETracheal Lavage

Tracheal Lavage will be performed on the control population patients and the tracheal fluid obtained from this procedure will be used as the research sample.

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes

Inclusion criteria

* Meet criteria of study population

Exclusion criteria

* Lack of informed consent/assent * Pulmonary disease in normal controls

Design outcomes

Primary

MeasureTime frame
pepsin concentration1 day

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026