gastroesophageal reflux disease regurgitation vomit
Conditions
Interventions
None listed
Sponsors
Academisch Medisch Centrum
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Healthy controls - Informed consent signed by caregiver(s) - >=34wks gestational age- 24 months postnatal age - Negative score in I-GERQ-R questionnaire (=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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome parameters: 1. Healthy controls: Salivary pepsin concentrations at day 1 to create reference values. 2. Symptomatic infants: correlation of baseline pepsin values and clinical outcome after initial conservative treatment (incl feed thickener) and (if applicable) PPI treatment. 3. Difference between salivary pepsin concentrations of healthy controls and symptomatic infants at baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Healthy controls: Day to day variability between samples taken at day 1 and day 2. Symptomatic infants: 1.Salivary pepsin concentrations after conservative treatment and feed thickeners compared to baseline and compared between responders/non responders 2.For non responders: salivary pepsin concentration after subsequent proton pump inhibitor treatment compared to baseline and after-conservative treatment pepsin levels. 3.Correlation between pH-MII parameters (below) and pepsin saliva concentrations at baseline, after initial standard treatment and after 4 weeks PPI treatment. a. Reflux index (% of the time the esophageal pH is | — |
Countries
Netherlands
Outcome results
None listed