title: Administration of a Multi-Strain Probiotic Product to Women in the Perinatal Period Differentially Affects the Breast Milk Cytokine Profile and May Have Beneficial Effects on Neonatal Gastrointestinal Functional Symptoms. A Randomized Clinical Trial.
abstract: BACKGROUND
  Probiotic supplementation to women during pregnancy and lactation can modulate breast milk composition, with immune benefits being transferred to their infants.
  
  
  OBJECTIVE
  The aim of the study was to evaluate the effect of high-dose probiotic supplementation to women during late pregnancy and lactation on cytokine profile and secretory IgA (sIgA) in breast milk and thus to study if differences in breast milk composition can affect lactoferrin and sIgA levels in stool samples of newborns. The safety of maternal probiotic administration on neonatal growth pattern and gastrointestinal symptoms were also evaluated.
  
  
  METHODS
  In a double-blind, placebo-controlled, randomized trial, 66 women took either the probiotic (n= 33) or a placebo (n= 33) daily. Levels of interleukins (IL-6, IL-10 and IL-1β), transforming growth factor-β1 (TGF-β1), and sIgA in breast milk; and the level of sIgA and lactoferrin in newborn stool samples were analyzed at birth and then again at one month of life. Antropometrical evaluation and analysis of gastrointestinal events in newborns was also performed.
  
  
  RESULTS
  Probiotic maternal consumption had a significant impact on IL6 mean values in colostrum and on IL10 and TGF-β1 mean values in mature breast milk. Fecal sIgA mean values were higher in newborns whose mothers took the probiotic product than in the control group. Probiotic maternal supplementation seems to decrease incidence of infantile colic and regurgitation in infants.
  
  
  CONCLUSIONS
  High-dose multi-strain probiotic administration to women during pregnancy influences breast milk cytokines pattern and sIgA production in newborns, and seems to improve gastrointestinal functional symptoms in infants.
authors: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. mariaelisabetta.baldassarre@uniba.it.
authors: Maria Elisabetta
authors: ME
authors: Baldassarre
authors: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. antonio.dimauro@uniba.it.
authors: Antonio
authors: A
authors: Di Mauro
authors: Department of Public Health and Infectious Disease, "Sapienza" University of Rome, Rome 00100, Italy. paola.mastromarino@uniroma1.it.
authors: Paola
authors: P
authors: Mastromarino
authors: Department of Interdisciplinary Medicine, "Aldo Moro" University of Bari, Bari 70100, Italy. margherita.fanelli@uniba.it.
authors: Margherita
authors: M
authors: Fanelli
authors: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. domenico_tine@libero.it.
authors: Domenico
authors: D
authors: Martinelli
authors: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. flaviaurbano@libero.it.
authors: Flavia
authors: F
authors: Urbano
authors: Department of Public Health and Infectious Disease, "Sapienza" University of Rome, Rome 00100, Italy. daniela.capobianco@uniroma1.it.
authors: Daniela
authors: D
authors: Capobianco
authors: Department of Biomedical Science and Human Oncology, Neonatology and Neonatal Intensive Care Unit, "Aldo Moro" University of Bari, Bari 70100, Italy. nicola.laforgia@uniba.it.
authors: Nicola
authors: N
authors: Laforgia
mesh_terms: D000328:Adult; D001644:Bifidobacterium / Q000254:growth & development / Q000276:immunology; D003085:Colic / Q000453:epidemiology / Q000276:immunology / Q000503:physiopathology / Q000517:prevention & control*; D016207:Cytokines / Q000032:analysis*; D004311:Double-Blind Method; D005260:Female; D041981:Gastrointestinal Tract / Q000276:immunology / Q000502:physiology* / Q000503:physiopathology; D006785:Hospitals, University; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007558:Italy / Q000453:epidemiology; D007774:Lactation; D007778:Lactobacillus / Q000254:growth & development / Q000276:immunology; D008297:Male; D039382:Maternal Nutritional Physiological Phenomena; D008895:Milk, Human / Q000737:chemistry* / Q000276:immunology; D018743:Perinatal Care; D011247:Pregnancy; D019936:Probiotics / Q000009:adverse effects / Q000627:therapeutic use*; D012306:Risk; D048249:Streptococcus thermophilus / Q000254:growth & development / Q000276:immunology; D014839:Vomiting / Q000209:etiology / Q000517:prevention & control
chemical_list: D016207:Cytokines
keywords: functional GI diseases; immunology; pediatric gastroenterology; probiotics/prebiotics