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Proton pump inhibitors are used to treat fussy and irritable babies who are thought to have gastroesophageal reflux. However, recent data suggests that proton pump inhibitors are not effective and pose unnecessary risks to the health of the infant.

Proton pump inhibitors are a class of drugs that inhibit the production of gastric acid, and have therefore been used to treat babies who have symptoms of gastroesophageal reflux, including excessive fussing and crying. Proton pump inhibitors act by attaching to and blocking the gastric proton pump, the final step in the process of gastric acid secretion. By irreversibly binding to the proton pump, the inhibitors prevent up to 99% of gastric acid secretion.

A recent systematic review has analysed the data from five clinical studies of proton pump inhibitor use in infants with excessive crying and irritability. The review reports that there is not a significant difference between the study groups that were analysed, and that the data does not provide evidence to support the use of proton pump inhibitors for this group of patients.

The concern with the use of proton pump inhibitors in infants is that using them has the potential to increase the risk of both gastrointestinal and respiratory tract infections. One of the clinical trials that was reviewed in the study showed a significantly increased rate of respiratory tract infections in the treatment group compared with the placebo group. The review suggests the available evidence demonstrates that proton pump inhibitors are not effective in this subset of patients, and the risks seem to outweigh the benefits for infants with crying and irritability.

There are ongoing studies assessing proton pump inhibitors for gastroesophageal reflux in infants. One study being conducted at the Medical University of Warsaw, Poland, is addressing the issue of increased risk of infection associated with proton pump inhibitor treatment. The study will evaluate the effectiveness of Lactobacillus GG at preventing infection in infants being treated with proton pump inhibitors. The study is recruiting infants who are less than 5 years old, with gastroesophageal reflux, who are being treated with proton pump inhibitors.


Gieruszczak-Białek, D, Konarska,Z,Skórka, A, Vandenplas, Y,Szajewska, H. “No Effect of Proton Pump Inhibitors on Crying and Irritability in Infants: Systematic Review of Randomized Controlled Trials” The Journal of Pediatrics doi:10.1016/j.jpeds.2014.11.030 Available from: Last Accessed: Jan 22, 2015.

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Written by Deborah Tallarigo, PhD

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