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Principal Investigator: Rachel Rosen, MD, MPH
Protocol Status: Open for recruitment
Trial Description: Gastroesophageal reflux (GER) or “heart burn” can cause inflammation to the esophagus (food pipe) as well as the airway (trachea and larynx) and can be responsible for asthma, cough or noisy breathy (stridor) in many patients with respiratory disease. Very little is known about the differences in reflux patterns between children with different respiratory diseases. We are conducting a study to examine the relationship between nonacid reflux and respiratory disease in children, specifically how common and severe GER is in children with respiratory disease and furthermore to see if there is a relationship between the amount of reflux and the severity of respiratory disease over time, with the ultimate goal of discovering how we can better treat these conditions. For this study we ask for permission to (1) anonymously review the results of the studies that the patient is undergoing as part of their clinical evaluation, (2) to give patients a short questionnaire on reflux symptoms and (3) to analyze a small sample of the patient’s saliva collected during the bronchoscopy for signs of reflux damage.
Study Procedures: During the procedure gastric fluid and bronch fluid are collected and a throat swab is performed. This is to analyze for markers of reflux damage as well as to compare the different flora from these regions. If a patient is having a laryngoscopy then a video of the patient’s airway is taken to check for reflux damage. If a patient is undergoing a pH-MII then these results are reviewed and the patient may be offered a simultaneous cough catheter that allows the association between cough and reflux events. Furthermore, the patient and/or parent is asked to fill out questionnaires. A parking voucher is distributed for participation in this study.
Recruitment Info: Children between the ages of 1 and 18 years with no prior surgery on their gastrointestinal tract who have had recurrent cough, stridor, or wheezing. Furthermore, these patients are eligible if their otolaryngologist, gastroenterologist or pulmonologist suspects that they may have reflux-related respiratory disease and they have already arranged for them to have an exam of the airway (laryngoscopy and/or bronchoscopy) and a gastrointestinal evaluation which includes an exam of the esophagus (endoscopy) and possibly an impedance-pH probe.
Recruitment Contact Name: Janine Amirault
Recruitment Contact Phone: 617-355-8072
Recruitment Contact Email: Janine.Amirault@childrens.harvard.edu
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