Pepsin As A Biomarker For Aspiration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00865995
Recruitment Status : Completed
First Posted : March 20, 2009
Last Update Posted : October 23, 2013
Information provided by (Responsible Party):
Nikki Johnston, Medical College of Wisconsin

Brief Summary:
Evaluation of tracheal pepsin as a biomarker for aspiration

Condition or disease Intervention/treatment
Aspiration Gastroesophageal Reflux Procedure: Tracheal Lavage

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.

Study Type : Observational
Actual Enrollment : 76 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Pepsin as a Biomarker for Aspiration Due to Gastroesophageal Reflux
Study Start Date : February 2008
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
Drug Information available for: Pepsin

Group/Cohort Intervention/treatment
patients undergoing elective procedures with intubation and no known respiratory pathology
Procedure: Tracheal 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.

patients with tracheostomy
patients with chronic lung disease or respiratory symptoms undergoing bronchoscopy

Primary Outcome Measures :
  1. pepsin concentration [ Time Frame: 1 day ]

Biospecimen Retention:   Samples Without DNA
Tracheal fluid

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normal children undergoing general endotracheal anesthesia Children with tracheostomies Children undergoing bronchoscopy Intubated children in PICU

Inclusion Criteria:

  • Meet criteria of study population

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00865995

United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Medical College of Wisconsin
Principal Investigator: Nikki Johnston, PhD Medical College of Wisconsin

Responsible Party: Nikki Johnston, Assistant Professor, Medical College of Wisconsin Identifier: NCT00865995     History of Changes
Other Study ID Numbers: CHW 08/26
GC 636
First Posted: March 20, 2009    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

Keywords provided by Nikki Johnston, Medical College of Wisconsin:
GE reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pepsin A
Gastrointestinal Agents