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The Efficacy and Safety of the Probiotic Bacterium Lactobacillus reuteri DSM 17938 for Infantile Colic: A Meta-Analysis of Randomized Controlled Trials.

Published on Oct 28, 2015in PLOS ONE2.78
· DOI :10.1371/journal.pone.0141445
Man Xu2
Estimated H-index: 2
(Xi'an Jiaotong University),
Jiao Wang2
Estimated H-index: 2
(Xi'an Jiaotong University)
+ 3 AuthorsXiao-Hong Liu2
Estimated H-index: 2
(Xi'an Jiaotong University)
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Abstract
Objective To evaluate the efficacy and safety of Lactobacillus reuteri DSM 17938 for treating infantile colic. Methods A systematic literature retrieval was carried out to obtain randomized controlled trials of L. reuteri DSM 17938 for infantile colic. Trials were performed before May 2015 and retrieved from the PubMed, EMBASE, Cochrane library, CNKI, WanFang, VIP, and CBM databases. Data extraction and quality evaluation of the trials were performed independently by two investigators. A meta-analysis was performed using STATA version 12.0. Results Six randomized controlled trials of 423 infants with colic were included. Of these subjects, 213 were in the L. reuteri group, and 210 were in the placebo group. Lactobacillus reuteri increased colic treatment effectiveness at two weeks (RR = 2.84; 95% CI: 1.24–6.50; p = 0.014) and three weeks (relative risk [RR] = 2.33; 95% CI: 1.38–3.93; P = 0.002) but not at four weeks (RR = 1.41; 95% CI: 0.52–3.82; P = 0.498). Lactobacillus reuteri decreased crying time (min/d) at two weeks (weighted mean difference [WMD] = –42.89; 95% CI: –60.50 to –25.29; P = 0.000) and three weeks (WMD = –45.83; 95% CI: –59.45 to –32.21; P = 0.000). In addition, L. reuteri did not influence infants’ weight, length or head circumference and was not associated with serious adverse events. Conclusions Lactobacillus reuteri possibly increased the effectiveness of treatment for infantile colic and decreased crying time at two to three weeks without causing adverse events. However, these protective roles are usurped by gradual physiological improvements. The study is limited by the heterogeneity of the trials and should be considered with caution. Higher quality, multicenter randomized controlled trials with larger samples are needed.
  • References (27)
  • Citations (27)
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References27
Newest
Published on Dec 1, 2015in Cephalalgia4.44
Matti Sillanpää43
Estimated H-index: 43
(UTU: University of Turku),
Maiju Saarinen14
Estimated H-index: 14
(UTU: University of Turku)
PurposeTo explore the association between infantile colic and adolescent migraine.MethodIn a randomized general population sample, families expecting their first child were prospectively followed for infantile colic and adolescent migraine.ResultsColic was diagnosed in 160 (13%) of 1267 infants until the age of 3 months. Migraine was ascertained in 129 (16%) of 787 adolescents at age 18 years. History of infantile colic was identified in 96 (12%) of 787 adolescents and no such history in 658 (88...
Published on Oct 1, 2015in MINERVA Pediatrica0.83
Nazan Kaymaz3
Estimated H-index: 3
,
Mehmet Erdem Uzun2
Estimated H-index: 2
+ 6 AuthorsEmel Sarı Gökten3
Estimated H-index: 3
Attention deficit and hyperactivity disorder (ADHD) and infantile colic (IC) are heterogeneous diseases which's cause are unknown. Besides the different hypotheses in the etiology of both disorders maldevelopment in the metabolism of neurotransmitters in the central nervous system have been implicated. The goal of this study is to investigate the relationship between IC and ADHD due to possible common etiological factor as maldevelopment in neurochemical process.A case-control study was carried ...
Guo-Lin Mi1
Estimated H-index: 1
(SDU: Shandong University),
Lei Zhao1
Estimated H-index: 1
(Boston Children's Hospital)
+ 3 AuthorsJin-Ke Xu1
Estimated H-index: 1
(CDC: Centers for Disease Control and Prevention)
Infant colic, excessive crying of unknown cause, is a major burden to families and effects about 10–30 % of infants. Despite decades of research, the exact cause and treatment of infant colic has remained elusive. The use of Lactobacillus reuteri (DSM 17938) in infant colic is somewhat controversial and hence, we designed this study to evaluate its efficacy in infantile colic. We recruited predominantly or exclusively breastfed infants, aged less than 4 months in a placebo controlled observation...
Published on May 15, 2015in Clinical Infectious Diseases9.05
Shira Doron14
Estimated H-index: 14
(Tufts Medical Center),
David R. Snydman70
Estimated H-index: 70
(Tufts Medical Center)
Probiotics have been used safely for years. Safety outcomes are inconsistently reported in published clinical trials. In 2011, a report released by the Agency for Healthcare Research and Quality concluded that, although the existing probiotic clinical trials reveal no evidence of increased risk, “the current literature is not well equipped to answer questions on the safety of probiotics in intervention studies with confidence.” Critics point out that the preponderance of evidence, including the ...
Published on Jan 1, 2015in The Journal of Pediatrics3.74
Kim Chau3
Estimated H-index: 3
(U of T: University of Toronto),
Eddy Lau2
Estimated H-index: 2
(U of T: University of Toronto)
+ 4 AuthorsGideon Koren80
Estimated H-index: 80
Objective To investigate the effectiveness of Lactobacillus reuteri DSM 17938 for the treatment of infantile colic in breastfed Canadian infants, compared with placebo. Study design A randomized, double-blind, placebo-controlled trial was conducted involving 52 infants with colic, according to modified Wessel criteria, who were assigned at random to receive L reuteri DSM 17938 (10 8 colony-forming units) (n = 24) or placebo (n = 28) for 21 days. Daily crying and fussing times were recorded in a ...
Published on Dec 1, 2014in Italian Journal of Pediatrics1.73
Francesco Savino24
Estimated H-index: 24
(UNITO: University of Turin),
Simone Ceratto4
Estimated H-index: 4
(UNITO: University of Turin)
+ 1 AuthorsLuca Cordero di Montezemolo14
Estimated H-index: 14
(UNITO: University of Turin)
Infantile colic is a common disturbance occurring in the first three months of life. It is a benign condition and one of the main causes of pediatric consultation in the early part of life because of its great impact on family life. Some pediatricians are prone to undervalue this issue mainly because of the lack of evidence based medicine guidelines. Up to now, there is no consensus concerning management and treatment. Literature reports growing evidence about the effectiveness of dietary, pharm...
Published on Sep 19, 2014in Pharmaceuticals
Luis Vitetta25
Estimated H-index: 25
,
Rachel Manuel2
Estimated H-index: 2
+ 3 AuthorsSamantha Coulson7
Estimated H-index: 7
At the time of birth, humans experience an induced pro-inflammatory beneficial event. The mediators of this encouraged activity, is a fleet of bacteria that assault all mucosal surfaces as well as the skin. Thus initiating effects that eventually provide the infant with immune tissue maturation. These effects occur beneath an emergent immune system surveillance and antigenic tolerance capability radar. Over time, continuous and regulated interactions with environmental as well as commensal micro...
Published on Sep 1, 2014in Beneficial Microbes2.94
Hania Szajewska64
Estimated H-index: 64
(Medical University of Warsaw),
Magdalena Urbańska6
Estimated H-index: 6
(Medical University of Warsaw)
+ 2 AuthorsRaanan Shamir48
Estimated H-index: 48
(TAU: Tel Aviv University)
Lactobacillus reuteri ATCC 55730 has been shown to provide a moderate clinical effect in the treatment of acute gastroenteritis (AGE) in children. However, as the L. reuteri ATCC 55730 strain was found to carry potentially transferable resistance traits for tetracycline and lincomycin, it was replaced by a new strain, L. reuteri DSM 17938, without unwanted plasmid-borne antibiotic resistance. Bioequivalence of the two strains has been suggested. We aimed to systematically evaluate data on the ef...
Published on Apr 1, 2014in BMJ27.60
Sung1
Estimated H-index: 1
(University of Melbourne),
Harriet Hiscock34
Estimated H-index: 34
(University of Melbourne)
+ 7 AuthorsMelissa Wake58
Estimated H-index: 58
(University of Melbourne)
Objective To determine whether the probiotic Lactobacillus reuteri DSM 17938 reduces crying or fussing in a broad community based sample of breastfed infants and formula fed infants with colic aged less than 3 months. Design Double blind, placebo controlled randomised trial. Setting Community based sample (primary and secondary level care centres) in Melbourne, Australia. Participants 167 breastfed infants or formula fed infants aged less than 3 months meeting Wessel’s criteria for crying or fus...
Published on Mar 1, 2014in Acta Paediatrica2.27
Ener Cagri Dinleyici19
Estimated H-index: 19
(Eskişehir Osmangazi University),
Yvan Vandenplas52
Estimated H-index: 52
(Vrije Universiteit Brussel)
Aim Guidelines consider certain probiotics useful in the management of acute gastroenteritis. This study evaluated the use of Lactobacillus (L) reuteri DSM 17938. Methods A multicentre, randomised, single-blind clinical trial was performed in hospitalised children with acute gastroenteritis lasting 12–72 h. Children received conventional therapy with, or without, 1 × 108 CFU of L. reuteri DSM 17938 for 5 days. The primary endpoint was the duration of diarrhoea and secondary outcomes were days of...
Cited By27
Newest
Published on Feb 1, 2020in Food Control4.25
Diwas Pradhan1
Estimated H-index: 1
(NDRI: National Dairy Research Institute),
Rashmi Hogarehalli Mallappa3
Estimated H-index: 3
(NDRI: National Dairy Research Institute),
Sunita Grover25
Estimated H-index: 25
(NDRI: National Dairy Research Institute)
Abstract Probiotics are live microorganisms which, when administered in adequate amounts, confer a health benefit on the host. Among the different microbial types, lactobacilli have been explored most extensively as potential therapeutics in human health. Lactobacilli belong to the human normal microbiota of the gastro-intestinal and urogenital tracts and have been traditionally used as starter cultures in the preparation of fermented foods. They are considered extremely safe as compared to phar...
Published on Jun 22, 2019in Archives of Disease in Childhood3.16
May Rivas‐Fernandez1
Estimated H-index: 1
,
Ana Diez Izquierdo + 1 AuthorsAlbert Balaguer13
Estimated H-index: 13
Maria is a 1.5-month-old healthy baby born at 39 weeks, mainly breastfed, although she has been fed artificial formula on a few occasions. In the last 2 weeks, she has been brought to the clinic with episodes of intense crying which last from 3 to 5 hours/day and occur 4–5 times a week. Her parents are finding it hard to soothe and calm her during these episodes, and find it very distressing. She undergoes a normal clinical examination and there do not seem to be any other associated conditions....
Published on Jan 2, 2019in Journal of Maternal-fetal & Neonatal Medicine1.57
Janki Deshmukh1
Estimated H-index: 1
(PMH: Princess Margaret Hospital for Children),
Mangesh Deshmukh4
Estimated H-index: 4
(St John of God Subiaco Hospital),
Sanjay Patole31
Estimated H-index: 31
(King Edward Memorial Hospital)
AbstractBackground: Neonatal jaundice requiring phototherapy is associated with significant socioeconomic burden including hospital readmission, prolonged hospital stay, and separation of the baby from mother.Objectives: To assess the efficacy and safety of probiotics in reducing the need for phototherapy and its duration in neonatal hyperbilirubinemia.Methods: A systematic review of randomized controlled trials (RCTs) of probiotic supplementation for prevention or treatment of jaundice in neona...
Published on Jan 1, 2019in Advances in Nutrition7.24
Julio Plaza-Díaz12
Estimated H-index: 12
(UGR: University of Granada),
Francisco Javier Ruiz-Ojeda7
Estimated H-index: 7
(UGR: University of Granada)
+ 1 AuthorsAngel Gil55
Estimated H-index: 55
Published on Dec 7, 2018in Beneficial Microbes2.94
Silvia Salvatore20
Estimated H-index: 20
(University of Insubria),
Licia Pensabene12
Estimated H-index: 12
+ 5 AuthorsYvan Vandenplas52
Estimated H-index: 52
(Vrije Universiteit Brussel)
The gut-brain axis has recently emerged as a key modulator of human health and the intestinal microbiome has a well-recognised pivotal role in this strong connection. The aim of this narrative review is to update and summarise the effect and clinical applicability of probiotics in paediatric neurogastroenterology. The Cochrane Database and PubMed were searched using keywords relating to different subtypes of functional gastrointestinal disorders (FGIDs) and their symptoms, those relating to the ...
Published on Dec 7, 2018in Beneficial Microbes2.94
Francesco Savino24
Estimated H-index: 24
,
Ilaria Galliano5
Estimated H-index: 5
+ 4 AuthorsMassimiliano Bergallo20
Estimated H-index: 20
Regulatory T cells induce immune homeostasis and the expression of Toll like receptors (TLRs); subsequent inflammatory cytokine release may be involved. Recent studies have shown a microbial imbalance in the gut of colicky infants (with a prevalence of gram-negative bacteria, such as Escherichia coli), and accumulating evidence has shown the efficacy of a probiotic (Lactobacillus reuteri) in breastfed subjects, but the underlying mechanism remains undefined. The study enrolled 59 infants younger...
Published on Dec 1, 2018in The Journal of Pediatrics3.74
J. Marc Rhoads25
Estimated H-index: 25
(University of Texas Health Science Center at Houston),
J Collinsjr122
Estimated H-index: 122
(BCM: Baylor College of Medicine)
+ 8 AuthorsMelissa R Van Arsdall9
Estimated H-index: 9
(University of Texas Health Science Center at Houston)
Objective To dissect potential confounding effects of breast milk and formula feeding on crying + fussing, fecal calprotectin, and gut microbiota in babies with colic. We hypothesized that infant colic is associated with gut inflammation linked to intestinal dysbiosis. Study design A nested case-control design of 3 of our studies was used to analyze clinical and laboratory data at presentation, comparing babies with colic with controls. All investigators other than the biostatistician were blind...
Published on Dec 1, 2018in Gastroenterology Clinics of North America3.37
Tu Mai (University of Texas Health Science Center at Houston), Nicole Y. Fatheree10
Estimated H-index: 10
(University of Texas Health Science Center at Houston)
+ 2 AuthorsJon Marc Rhoads7
Estimated H-index: 7
Published on Oct 18, 2018in Nutrients4.17
Yuying Liu12
Estimated H-index: 12
,
Jane J. Alookaran1
Estimated H-index: 1
(University of Texas Health Science Center at Houston),
J. Marc Rhoads1
Estimated H-index: 1
Probiotics have been used to ameliorate gastrointestinal symptoms since ancient times. Over the past 40 years, probiotics have been shown to impact the immune system, both in vivo and in vitro. This interaction is linked to gut microbes, their polysaccharide antigens, and key metabolites produced by these bacteria. At least four metabolic pathways have been implicated in mechanistic studies of probiotics, based on mechanistic studies in animal models. Microbial–immune system crosstalk has been l...
Published on Oct 1, 2018in The Journal of Clinical Pharmacology2.92
Yuying Liu12
Estimated H-index: 12
(University of Texas Health Science Center at Houston),
Dat Q. Tran6
Estimated H-index: 6
(University of Texas Health Science Center at Houston),
J. Marc Rhoads25
Estimated H-index: 25
(University of Texas Health Science Center at Houston)