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Treatment of Gastroesophageal Reflux Disease in Infants

RecruitingPhase 4Ages 1 Month - 1 YearAllOdense University Hospital
NCT06255886 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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)

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📋 Eligibility rules (as published)
Inclusion Criteria: * Infants diagnosed with gastroesophageal reflux disease (GERD) * Age \< 1 year at the time of referral * Age \>1 month at start of treatment * At least 3 reflux episodes/daily in average * At least one of following troublesome symptoms are present: Crying of unknown reason, discomfort/irritability, problems gaining weight/ weightloss, rejects the breast or bottle, apnea, back-arching. Exclusion Criteria: * Children with diagnosed or suspected syndrome /genetic disorder * Congenital malformations (minor deformities are excepted) * Abdominal surgery * Metabolic disease * Treatment with proton pump inhibitor within the last week * Allergy for proton pump inhibitors * Allergy for cow milk protein * Infants on Cow's milk free diet
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What it tests

  • Protein pump inhibitor.
  • Mother or infant diet
  • Placebo
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Where

3 sites
Paediatric Department, Hospital of Southern Jutland
Aabenraa, Denmark
Børnelægecentret v/Kasper Dalby
Odense, Denmark
H.C Andersen Childrens' Hospital
Odense, Denmark
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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