Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.

OBJECTIVE: To assess the safety of probiotic Lactobacillus reuteri strain Deutsche Sammlung von Mikroorganismen (DSM) 17938 with daily administration to healthy infants with colic and to determine the effect of L reuteri strain DSM 17938 on crying, fussing, inflammatory, immune, and microbiome variables. STUDY DESIGN: We performed a controlled, double-blinded, phase 1 safety and tolerability trial in healthy breast-fed infants with colic, aged 3 weeks to 3 months, randomly assigned to L reuteri strain DSM 17938 (5 × 108 colony-forming units daily) or placebo for 42 days and followed for 134 days. RESULTS: Of 117 screened infants, 20 were randomized to L reuteri strain DSM 17938 or placebo (sunflower oil) (in a 2:1 ratio) with 80% retention. Eleven of the 20 (55%) presented with low absolute neutrophil counts (<1500/mm3), which resolved in all subjects by day 176. L reuteri strain DSM 17938 produced no severe adverse events and did not significantly change crying time, plasma bicarbonate, or inflammatory biomarkers. Fecal calprotectin decreased rapidly in both groups. In the infants with dominant fecal gram negatives (Klebsiella, Proteus, and Veillonella), resolution of colic was associated with marked decreases in these organisms. CONCLUSIONS: Daily administration of L reuteri strain DSM 17938 appears to be safe in newborn infants with colic, including those with neutropenia, which frequently coexists. A placebo response of 66% suggests that many infants with colic will have resolution within 3 weeks. TRIAL REGISTRATION: ClinicalTrials.gov: NCT01849991.

The economic burden of gastroschisis: costs of a birth defect.

BACKGROUND: Intestinal dysfunction and feeding intolerance are comorbidities associated with the abdominal wall birth defect of gastroschisis (GS). These factors contribute to prolonged hospitalization in this population of patients. The purpose of this study was to evaluate the economic burden on a state and national level. METHODS: From 2007-2011, the Healthcare Cost and Utilization Project database was queried for the following national and state of Texas data: number of discharges, length of stay (LOS), costs, and charges for all pediatric hospital stays ± CPT code 54.71 denoting GS repair for infants aged <1 y. The effect of GS on LOS, cost, and charges was calculated by the weighted average of the differences and is represented by the combined estimated difference (CED). RESULTS: Infants <1 y represent 74% of all pediatric discharges nationally and only 0.04% of these discharges are accounted for by GS patients. Nationally, GS patients had significantly longer LOS (CED 38.5 ± 0.9 d, P < 0.0001); increased costs (CED $79,733 ± $2119, P < 0.0001); and charges (CED $249,999 ± $9562, P < 0.0001). The Texas state data mirrored our findings for the national data. There was no significant difference in the LOS, costs, and charges between the national and state level. CONCLUSIONS: Our study shows that GS patients represent an extremely small minority of national and Texas pediatric discharges; however, these patients LOS and costs greatly exceed non-GS patients. Further investigation into factors influencing the development of intestinal dysfunction in these patients is needed to significantly impact the economic burden of the abdominal wall birth defect of GS.