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Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial.
J Pediatr 2017; 191:170-178.e2JPed

Abstract

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.

Authors+Show Affiliations

Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Department of Microbiology, Immunology & Parasitology Louisiana State University Health Sciences Center, New Orleans, LA.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Division of Clinical and Translational Sciences, Department of Internal Medicine, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX; Biostatistics/Epidemiology/Research Design (BERD) Component, Center for Clinical and Translational Sciences (CCTS), the University of Texas Health Science Center at Houston, Houston, TX.Division of Clinical and Translational Sciences, Department of Internal Medicine, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX; Biostatistics/Epidemiology/Research Design (BERD) Component, Center for Clinical and Translational Sciences (CCTS), the University of Texas Health Science Center at Houston, Houston, TX; Division of Epidemiology, Human Genetics, and Environmental Sciences (EHGES), University of Texas School of Public Health at Houston, TX.Biostatistics/Epidemiology/Research Design (BERD) Component, Center for Clinical and Translational Sciences (CCTS), the University of Texas Health Science Center at Houston, Houston, TX.Department of Microbiology, Immunology & Parasitology Louisiana State University Health Sciences Center, New Orleans, LA.Department of Microbiology, Immunology & Parasitology Louisiana State University Health Sciences Center, New Orleans, LA.Memorial Hermann Hospital Investigational Drug Services, Memorial Hermann Hospital, Houston, TX.Memorial Hermann Hospital Investigational Drug Services, Memorial Hermann Hospital, Houston, TX.Clinical Research Center, Memorial Hermann Hospital, Houston, TX.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX.Department of Pediatrics, the University of Texas Health Science Center at Houston McGovern Medical School, Houston, TX. Electronic address: J.Marc.Rhoads@uth.tmc.edu.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, N.I.H., Extramural

Language

eng

PubMed ID

28969890

Citation

Fatheree, Nicole Y., et al. "Lactobacillus Reuteri for Infants With Colic: a Double-Blind, Placebo-Controlled, Randomized Clinical Trial." The Journal of Pediatrics, vol. 191, 2017, pp. 170-178.e2.
Fatheree NY, Liu Y, Taylor CM, et al. Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Pediatr. 2017;191:170-178.e2.
Fatheree, N. Y., Liu, Y., Taylor, C. M., Hoang, T. K., Cai, C., Rahbar, M. H., ... Rhoads, J. M. (2017). Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. The Journal of Pediatrics, 191, pp. 170-178.e2. doi:10.1016/j.jpeds.2017.07.036.
Fatheree NY, et al. Lactobacillus Reuteri for Infants With Colic: a Double-Blind, Placebo-Controlled, Randomized Clinical Trial. J Pediatr. 2017;191:170-178.e2. PubMed PMID: 28969890.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Lactobacillus reuteri for Infants with Colic: A Double-Blind, Placebo-Controlled, Randomized Clinical Trial. AU - Fatheree,Nicole Y, AU - Liu,Yuying, AU - Taylor,Christopher M, AU - Hoang,Thomas K, AU - Cai,Chunyan, AU - Rahbar,Mohammad H, AU - Hessabi,Manouchehr, AU - Ferris,Michael, AU - McMurtry,Valarie, AU - Wong,Christine, AU - Vu,Ta, AU - Dancsak,Theresa, AU - Wang,Ting, AU - Gleason,Wallace, AU - Bandla,Vinay, AU - Navarro,Fernando, AU - Tran,Dat Q, AU - Rhoads,J Marc, Y1 - 2017/09/29/ PY - 2017/01/20/received PY - 2017/07/07/revised PY - 2017/07/19/accepted PY - 2017/10/4/pubmed PY - 2017/12/12/medline PY - 2017/10/4/entrez KW - Barr diary KW - crying KW - immunology KW - infant KW - microbiome KW - neutropenia KW - regulatory T cells SP - 170 EP - 178.e2 JF - The Journal of pediatrics JO - J. Pediatr. VL - 191 N2 - 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. SN - 1097-6833 UR - https://www.unboundmedicine.com/medline/citation/28969890/Lactobacillus_reuteri_for_Infants_with_Colic:_A_Double_Blind_Placebo_Controlled_Randomized_Clinical_Trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(17)31039-9 DB - PRIME DP - Unbound Medicine ER -