Treatment of Gastroesophageal Reflux Disease in Infants
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age1-1
SponsorOdense University Hospital
About this trial
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)
Eligibility criteria
Qualifiers
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
Disqualifiers
Children with diagnosed or suspected syndrome /genetic disorder
Congenital malformations (minor deformities are excepted)
Abdominal surgery
Metabolic disease
Trial design
Treatments tested in this trial
- Protein pump inhibitor.
- Mother or infant diet
- Placebo
Treatment groups
96 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov