Salivary pepsin for diagnosis of gastro-oesophageal reflux disease in infants (0-18 months)

Completed

Conditions: gastroesophageal reflux disease
regurgitation
vomit
10017977

Registration Number: NL-OMON45027

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 150

Inclusion Criteria

Healthy controls
- Informed consent signed by caregiver(s)
- >=34wks gestational age- 24 months postnatal age
- Negative score in I-GERQ-R questionnaire (<16);Symptomatic infants
- Informed consent signed by caregiver(s)
- >=34wks GA - 18 months PNA
- Attending either a general pediatric outpatient clinic or specific pediatric gastroenterology department for gastro esophageal reflux related symptoms
- Positive score on I-GERQ-R questionnaire (>=16 points)

Exclusion Criteria

Valid for both healthy subjects and symptomatic infants:
- Known structural gastro-intestinal abnormalities
- Previous gastro-intestinal surgery
- Neurological syndromes and development disorders
- Any condition that would make it unsafe for the subject to participate determined by the treating physician.
- Use of anti gastro esophageal reflux medications (prokinetics, erythromycin, proton pump inhibitors, H2 receptor antagonists, antacida) in the last 5 days before inclusion.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary outcome parameters:<br /><br><br /><br>1. Healthy controls: Salivary pepsin concentrations at day 1 to create<br /><br>reference values.<br /><br>2. Symptomatic infants: correlation of baseline pepsin values and clinical<br /><br>outcome after initial conservative treatment (incl feed thickener) and (if<br /><br>applicable) PPI treatment.<br /><br>3. Difference between salivary pepsin concentrations of healthy controls and<br /><br>symptomatic infants at baseline</p><br>

Secondary Outcome Measures