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Cow-Milk-Protein Free Diet vs Omeprazole for Infant GERD
NCT06255886Phase 4
Key facts
- Status
- Recruiting
- Start
- Oct 2025
- Primary completion
- Dec 2026
- Countries
- 1
- Sponsor
- University Hospital Odense
- Modality
- Small Molecules
- Drugs
- omeprazole
- Conditions
- gastroesophageal reflux disease (GERD)
01
Overview
Phase 4, randomised, double-blind trial of omeprazole in gastroesophageal reflux disease (GERD) (3 arms), sponsored by University Hospital Odense. Primary endpoint: Change from baseline in reflux episodes at 4 weeks. Started Oct 2025; status: recruiting.
02
Design
3 arms- Study design
- RandomizedDouble-blind
Proton pump inhibitor
Omeprazole 1 mg/kg/day
Mother or infant diet
Cow milk protein free diet
Placebo
Placebo matching Omeprazole
03
Who it enrols
Infants <1 year with GERD, >3 reflux episodes/day. Excludes syndromes, malformations, prior PPI use.
04
Endpoints
Primary
Change from baseline in reflux episodes
Secondary
Change from baseline in weight
Change from baseline in the number of reflux episodes with visible blood
Change from baseline in the number of episodes with discomfort
Change from baseline in the numbers of episodes with crying
Change from baseline in the number of episodes of refusing breast/ bottle
Change from baseline in the number of episodes with short breathing pauses
Change from baseline in the number of episodes with paleness/blue color in face or lips
Change from baseline in the number of episodes with troublesome breathing/cough
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