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Treatment of Gastroesophageal Reflux Disease in Infants

StatusRecruiting
PhasePhase 4
Started
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Record History

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  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 3
    • Primary and study completion dates: Oct 1, 2026 to Dec 26, 2026
    • Start date changed from estimate of Oct 1, 2025 to Oct 27, 2025
    v5
  2. Primary and study completion dates: Jun 1, 2025 to Oct 1, 2026v4 Show 5 more changesShow less
    • Start date: Oct 1, 2024 to Oct 1, 2025
    • Primary endpoint revised
    • Interventions: Mother or infant diet (Behavioral), Placebo (Drug), Protein pump inhibitor. Continuing nutrition containing cows' milk protein. (Drug) to Mother or infant diet (Behavioral), Placebo (Drug), Protein pump inhibitor. (Drug)
    • Secondary endpoints: 9 to 10
    • Collaborators shortened, about 4 words
  3. Start date: Jun 1, 2024 to Oct 1, 2024v3
  4. Study description expanded, about 1 wordv2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Gastroesophageal reflux disease in infants is not fully understood. Infants are prescribed medical treatments that may not be effective or that contribute to adverse side effects and lead to concerns and expenses for the parents and healthcare system. Current guidelines recommend cow-milk-protein free diet as a first-line treatment, but these recommendations are based on weak evidence. This study investigate the efficacy of a cow-milk-protein free diet compared to treatment with a proton pump inhibitor (omeprazole)
Trial Details
NCT Number NCT06255886
Lead Sponsor Odense University Hospital
Conditions
(from sponsor)		 Gastroesophageal Reflux, Infant, Newborn, Diseases
Related terms Gastroesophageal Reflux, Infant, Newborn, Diseases
Enrollment 96 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov