Saliva testing for the diagnosis of reflux disease in infants
- Conditions
- Gastroesophageal reflux, Gastro-oesophageal reflux, Gastroesophageal reflux disease, Gastro-oesophageal reflux disease, infant, pediatrics
- Registration Number
- NL-OMON28151
- Lead Sponsor
- Academic Medical Centre, Emma Children's hospital, Amsterdam
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 300
Inclusion Criteria
1. Healthy controls
- Informed consent signed by caregiver(s)
Exclusion Criteria
- Known structural GI abnormalities
- Previous gastro-intestinal (GI) surgery
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Healthy controls: <br /><br>- Salivary pepsin A concentrations at day 1 <br /><br><br /><br>2. Symptomatic infants: <br /><br>- Baseline salivary pepsin A concentrations compared to healthy controls <br /><br>- Correlation of baseline salivary pepsin A concentrations with clinical outcome during standardized treatment.
- Secondary Outcome Measures
Name Time Method 1. Healthy controls: <br /><br>Day to day variability between samples taken at day 1 and day 2.<br /><br><br /><br>2. Symptomatic infants: <br /><br>- Correlation of baseline salivary pepsin and pH-MII parameters after two weeks of unsuccessful (no complete response) conservative treatment<br /><br>- Correlation of salivary pepsin and pH-MII parameters after two weeks of unsuccesful (no complete response) conservative treatment<br /><br>- Correlation of salivary pepsin and I-GERQ-R scores at different time points.