Short summary

Gastroesophageal Reflux Disease is common in infants. An increasing number of patients are treated for the condition, even though the evidence for the treatment is scarce. This double-blinded randomized controlled trial investigates the efficacy of 4 weeks of treatment with either a Cow's milk-free diet or a Proton pump inhibitor, compared to a placebo group. The outcome is observed by the parents, and registered daily in an app.

Rationale

Gastroesophageal Reflux Disease (GERD) is a common condition in infants, with a prevalence in the literature between 23% and 40%. Infants with GERD experience multiple reflux episodes and troublesome symptoms such as failure to thrive, irritability, and back arching. The condition may be caused by an allergy to Cow's Milk Protein (CMP), and current international guidelines recommend change of nutrition to a CMP-free diet before considering treatment with a Proton Pump Inhibitor (PPI). However, the evidence for this recommendation is weak. To address this knowledge gap, we plan to conduct a multicenter, randomized controlled trial (RCT) to investigate the efficacy of a CMP-free diet or PPI, compared to placebo in infants diagnosed with GERD.

Description of the cohort

Infants diagnosed with GERD from H.C Andersen Children's Hospital, Odense, Department of Child and Youth, Hospital of Sønderjylland, or Paediatric Clinic by Kasper Dalby. Age of the patients: 2 weeks to 12 months.

Data and biological material

Questionnaire data registered in MyCap Data from the patient journal Blod samples

Collaborating researchers and departments

Department of Paediatrics, H.C Andersen Child and Youth Hospital

• Gitte Zachariassen, Professor
• Josefine Gradman, PhD

Paediatric Clinic by Kasper Dalby

• Kasper Dalby, PhD

Department of Research, Sygehus Sønderjylland

• Christian Backer Mogensen, Professor