Background and aims Gastro-esophageal reflux disease (GERD) is defined by persistent reflux episodes associated with significant symptoms or complications. In infants and toddlers GERD symptoms are hard to distinguish and usually vary with the child’s age. There is no consensus concerning GERD treatment in infants, especially regarding prokinetics. Therefore, this study aims to evaluate the effectiveness of erythromycin as prokinetic agent in infants and toddlers with GERD.

Methods This retrospective study evaluated 47 patients with GERD, admitted over a 2 year period in a paediatric department. We included patients under the age of 24 months with digestive and extra digestive symptoms proved with GERD clinically or by imagistic findings. We excluded those who received prokinetic or proton pump inhibitor therapy in the last week before the study and patients with respiratory and neurological diseases which could determine similar extra digestive symptoms. Regarding the pharmacological therapy, the patients were divided in 3 study groups: group A received erythromycin 3–5 mg/kg/day for one month, group B received esomeprazole 0.5–1 mg/kg/day for one month, while group C received erythromycin 3–5 mg/kg/day combined with esomeprazole 0.5–1 mg/kg/day for one month. All patients followed the same preceding dietary regimen during the entire duration of the therapy. Total or partial improvement in symptoms was considered as favourable clinical outcome while the persistence of symptoms was recorded as unfavourable clinical outcome.

Results Out of 47 patients 63.8% were male, 76.6% were infants and 29.8% were born preterm. Sixteen of the 17 patients in group A (94.1%) had a favourable clinical outcome compared to only six out of 14 patients in group B (42.8%). This difference was highly statistically significant (p=0.004). Comparing the effectiveness of therapy between group A and group C, erythromycin alone was significantly more effective than therapy with erythromycin combined with esomeprazole (p=0.039). No side effects were noticed in neither of the groups taking erythromycin.

Conclusion Our study proves that erythromycin is a safe and effective therapy for infants and toddlers with GERD. More studies with larger number of cases are necessary to confirm these data.