Saliva testing for the diagnosis of reflux disease in infants

Salivary pepsin as a diagnostic test in infant gastro-oesophageal reflux disease (GERD)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON28151

Enrollment

300

Registered

2014-05-12

Start date

2014-05-15

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal reflux, Gastro-oesophageal reflux, Gastroesophageal reflux disease, Gastro-oesophageal reflux disease, infant, pediatrics

Interventions

2 weeks of 1 daily 1 mg/kg omeprazol therapy in symptomatic children not responding to 2 weeks of conservative treatment.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Healthy controls - Informed consent signed by caregiver(s) - At least 34wks gestational age (GA) - At most 24 months post natal age (PNA) - Attending a regular health care check up at Childs health clinic or a physician for an unrelated problem - Negative score in I-GERQ-R questionnaire 2. Symptomatic infants - Informed consent signed by caregiver(s) - At leaast 34wks GA - At most 18 months post natal age (PNA) - Attending a regular health care check up at Childs health clinic or a physician for GER related symptoms - Positive score on I-GERQ-R questionnaire

Exclusion criteria

Exclusion criteria: - Known structural GI abnormalities - Previous gastro-intestinal (GI) 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 GER medications (prokinetics, erytromycin, PPI, H2RA, antacida) in the last 5 days before inclusion.

Design outcomes

Primary

Measure	Time frame
1. Healthy controls: - Salivary pepsin A concentrations at day 1 2. Symptomatic infants: - Baseline salivary pepsin A concentrations compared to healthy controls - Correlation of baseline salivary pepsin A concentrations with clinical outcome during standardized treatment.	—

Secondary

Measure	Time frame
1. Healthy controls: Day to day variability between samples taken at day 1 and day 2. 2. Symptomatic infants: - Correlation of baseline salivary pepsin and pH-MII parameters after two weeks of unsuccessful (no complete response) conservative treatment - Correlation of salivary pepsin and pH-MII parameters after two weeks of unsuccesful (no complete response) conservative treatment - Correlation of salivary pepsin and I-GERQ-R scores at different time points.	—

Measure

Time frame

1. Healthy controls: Day to day variability between samples taken at day 1 and day 2. 2. Symptomatic infants: - Correlation of baseline salivary pepsin and pH-MII parameters after two weeks of unsuccessful (no complete response) conservative treatment - Correlation of salivary pepsin and pH-MII parameters after two weeks of unsuccesful (no complete response) conservative treatment - Correlation of salivary pepsin and I-GERQ-R scores at different time points.

—

Contacts

Public ContactMarc A. Benninga

Kinderarts MDL, AMC, H7-248 P.O. Box 22660

m.a.benninga@amc.nl+31 (0)20 5663053 / +31 (0)20 5666297

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)