Valerie Sung1, Frank D'Amico2,3, Michael D Cabana4, Kim Chau5, Gideon Koren5, Francesco Savino6, Hania Szajewska7, Girish Deshpande8, Christophe Dupont9, Flavia Indrio10, Silja Mentula11, Anna Partty12, Daniel Tancredi13. 1. Murdoch Children's Research Institute, The Royal Children's Hospital, and the University of Melbourne, Melbourne, Victoria, Australia; valerie.sung@rch.org.au. 2. Department of Mathematics, Duquesne University, Pittsburgh, Pennsylvania. 3. University of Pittsburgh Medical Center St. Margaret's Hospital, Pittsburgh, Pennsylvania. 4. Department of Pediatrics, Epidemiology and Biostatistics, School of Medicine, University of California, San Francisco, San Francisco, California. 5. University of Toronto and The Hospital for Sick Children, Toronto, Ontario, Canada. 6. Ospendale Infantile Regina Margherita, Citta della Salute e della Scienza di Torino, Torino, Italy. 7. Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland. 8. Department of Neonatology, Nepean Hospital and Sydney Medical School Nepean, University of Sydney, Sydney, New South Wales, Australia. 9. Department of Pediatric Gastroenterology, Paris Descartes University and Necker-Enfants Malades Hospital, Paris, France. 10. Department of Pediatrics, University of Bari, Bari, Italy. 11. Bacteriology Unit, National Institute for Health and Welfare, Helsinki, Finland. 12. Department of Pediatrics and Adolescent Medicine, Turku University Hospital, Turku, Finland; and. 13. Department of Pediatrics, University of California Davis Health System, Sacramento, California.
Abstract
CONTEXT: Lactobacillus reuteri DSM17938 has shown promise in managing colic, but conflicting study results have prevented a consensus on whether it is truly effective. OBJECTIVE: Through an individual participant data meta-analysis, we sought to definitively determine if L reuteri DSM17938 effectively reduces crying and/or fussing time in infants with colic and whether effects vary by feeding type. DATA SOURCES: We searched online databases (PubMed, Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, the Database of Abstracts of Reviews of Effects, and Cochrane), e-abstracts, and clinical trial registries. STUDY SELECTION: These were double-blind randomized controlled trials (published by June 2017) of L reuteri DSM17398 versus a placebo, delivered orally to infants with colic, with outcomes of infant crying and/or fussing duration and treatment success at 21 days. DATA EXTRACTION: We collected individual participant raw data from included studies modeled simultaneously in multilevel generalized linear mixed-effects regression models. RESULTS: Four double-blind trials involving 345 infants with colic (174 probiotic and 171 placebo) were included. The probiotic group averaged less crying and/or fussing time than the placebo group at all time points (day 21 adjusted mean difference in change from baseline [minutes] -25.4 [95% confidence interval (CI): -47.3 to -3.5]). The probiotic group was almost twice as likely as the placebo group to experience treatment success at all time points (day 21 adjusted incidence ratio 1.7 [95% CI: 1.4 to 2.2]). Intervention effects were dramatic in breastfed infants (number needed to treat for day 21 success 2.6 [95% CI: 2.0 to 3.6]) but were insignificant in formula-fed infants. LIMITATIONS: There were insufficient data to make conclusions for formula-fed infants with colic. CONCLUSIONS: L reuteri DSM17938 is effective and can be recommended for breastfed infants with colic. Its role in formula-fed infants with colic needs further research.
CONTEXT: Lactobacillus reuteri DSM17938 has shown promise in managing colic, but conflicting study results have prevented a consensus on whether it is truly effective. OBJECTIVE: Through an individual participant data meta-analysis, we sought to definitively determine if L reuteri DSM17938 effectively reduces crying and/or fussing time in infants with colic and whether effects vary by feeding type. DATA SOURCES: We searched online databases (PubMed, Medline, Embase, the Cumulative Index to Nursing and Allied Health Literature, the Database of Abstracts of Reviews of Effects, and Cochrane), e-abstracts, and clinical trial registries. STUDY SELECTION: These were double-blind randomized controlled trials (published by June 2017) of L reuteri DSM17398 versus a placebo, delivered orally to infants with colic, with outcomes of infant crying and/or fussing duration and treatment success at 21 days. DATA EXTRACTION: We collected individual participant raw data from included studies modeled simultaneously in multilevel generalized linear mixed-effects regression models. RESULTS: Four double-blind trials involving 345 infants with colic (174 probiotic and 171 placebo) were included. The probiotic group averaged less crying and/or fussing time than the placebo group at all time points (day 21 adjusted mean difference in change from baseline [minutes] -25.4 [95% confidence interval (CI): -47.3 to -3.5]). The probiotic group was almost twice as likely as the placebo group to experience treatment success at all time points (day 21 adjusted incidence ratio 1.7 [95% CI: 1.4 to 2.2]). Intervention effects were dramatic in breastfed infants (number needed to treat for day 21 success 2.6 [95% CI: 2.0 to 3.6]) but were insignificant in formula-fed infants. LIMITATIONS: There were insufficient data to make conclusions for formula-fed infants with colic. CONCLUSIONS: L reuteri DSM17938 is effective and can be recommended for breastfed infants with colic. Its role in formula-fed infants with colic needs further research.
Authors: Mary Ellen Sanders; Daniel J Merenstein; Gregor Reid; Glenn R Gibson; Robert A Rastall Journal: Nat Rev Gastroenterol Hepatol Date: 2019-07-11 Impact factor: 46.802
Authors: Molly Fox; S Melanie Lee; Kyle S Wiley; Venu Lagishetty; Curt A Sandman; Jonathan P Jacobs; Laura M Glynn Journal: Dev Psychopathol Date: 2021-06-10