In Reply We thank Dr Sanaie and colleagues for their interest in our article.1 Dr Sanaie argues we used a nonmentioned oil as placebo that could have changed the gut behavior and enhanced or decreased the frequency of infantile colic, regurgitation, and functional constipation. However, we adopted a mentioned pharmaceutical oily suspension of sunflower and medium-chain triglyceride oil containing probiotic bacteria in the intervention group and an equal oily suspension without probiotic bacteria in the placebo group. The only difference in oil between the groups was the presence of live bacteria. It is likely that probiotic supplementation had the majority of functional gastrointestinal disorders because the same oil was used for the 2 different formulations. We agree with Dr Sanaie about maternal diet as an influential factor associated with colic crying2 and no intervention on maternal diet had been done during our probiotic supplementation in breast-fed infants. However, our study included both breast-fed and formula-fed infants and no statistical differences were found in results comparing these subpopulations in infants supplemented with probiotic bacteria. Finally, Dr Sanaie is doubtful of the accuracy and validity of the information provided by parents because these aspects may be too subjective and were not reported daily in a medical record by a physician. The diagnosis of the disorders was always performed by an expert pediatric gastroenterologist following the Rome III criteria.3 In this approach, the subjective evaluation of symptoms by parent or caretaker is fundamental in physicians’ clinical practice, depending on reports and interpretations of the parents. The use of a diary recorded by parents has been used in several previous studies.4,5 Moreover, a recent article by Sung et al6 indicates clinical diaries reviewed by an expert pediatrician is a reliable method in clinical trial protocol for infantile colic.
Indrio F, Di Mauro A, Riezzo G. Prophylactic Use of a Probiotic in the Prevention of Colic, Regurgitation, and Functional Constipation—Reply. JAMA Pediatr. 2014;168(8):778. doi:10.1001/jamapediatrics.2014.368