From the 1Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX; 2Department of Microbiology, Immunology & Parasitology Louisiana State University Health Sciences Center, New Orleans, LA; 3Division of Clinical and Translational Sciences, Department of Internal Medicine, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX; 4Biostatistics/Epidemiology/Research Design (BERD) Component, Center for Clinical and Translational Sciences (CCTS), the University of Texas Health Science Center at Houston, Houston, TX; 5Division of Epidemiology, Human Genetics, and Environmental Sciences (EHGES), University of Texas School of Public Health at Houston, TX; 6Memorial Hermann Hospital Investigational Drug Services, Memorial Hermann Hospital, Houston, TX; and 7Clinical Research Center, Memorial Hermann Hospital, Houston, TX
Checking for direct PDF access through Ovid
ObjectiveTo 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 designWe 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.ResultsOf 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.ConclusionsDaily 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 registrationClinicalTrials.gov: NCT01849991.