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BMJ Open. 2014 Dec 4;4(12):e006475. doi: 10.1136/bmjopen-2014-006475.

Lactobacillus reuteri DSM 17938 for managing infant colic: protocol for an individual participant data meta-analysis.

Author information

1
Murdoch Childrens Research Institute, Royal Children's Hospital, The University of Melbourne, Melbourne, Victoria, Australia.
2
Department of Pediatrics, Epidemiology and Biostatistics, University of California, San Francisco (UCSF) School of Medicine, San Francisco, California, USA.
3
Duquesne University/UPMC St. Margaret Hospital, Pittsburgh, Pennsylvania, USA.
4
Department of Children's health division and NICU, Nepean Hospital Sydney, Sydney, New South Wales, Australia Sydney Medical School Nepean, University of Sydney, Sydney, New South Wales, Australia.
5
Department of Pediatric Gastroenterology, Paris Descartes University, Necker Hospital, Paris, France.
6
Department of Pediatrics, University of Bari, Bari, Italy.
7
Bacteriology Unit, National Institute for Health and Welfare, Helsinki, Finland.
8
Department of Pediatrics and Adolescent Medicine, Turku University Hospital, Turku, Finland.
9
Ospedale Infantile Regina Margherita, Città della Salute e della Scienza di Torino, Torino, Italy.
10
Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
11
Department of Pediatrics, UC Davis Health System, Sacramento, California, USA.

Abstract

INTRODUCTION:

Infant colic, or excessive crying of unknown cause in infants less than 3 months old, is common and burdensome. Its aetiology is undetermined, and consensus on its management is still lacking. Recent studies suggest a possible link between infant colic and gut microbiota, indicating probiotics to be a promising treatment. However, only a few strains have been tested, and results from randomised controlled trials are conflicting. It is important to clarify whether probiotics are effective for treating infant colic in general, and to identify whether certain subgroups of infants with colic would benefit from particular strains of probiotics.

METHODS AND ANALYSIS:

Through an individual participant data meta-analysis (IPDMA), we aim to identify whether the probiotic Lactobacillus reuteri DSM 17938 is effective in the management of infant colic, and to clarify whether its effects differ according to feeding method (breast vs formula vs combined), proton pump inhibitor exposure, and antibiotic exposure. The primary outcomes are infant crying duration and treatment success (at least 50% reduction in crying time from baseline) at 21 days postintervention. Individual participant data from all studies will be modelled simultaneously in multilevel generalised linear mixed-effects regression models to account for the nesting of participants within studies. Subgroup analyses of participant-level and intervention-level characteristics will be undertaken on the primary outcomes to assess if the intervention effect differs between certain groups of infants.

ETHICS AND DISSEMINATION:

Approved by the Royal Children's Hospital Human Research Ethics Committee (HREC 34081). Results will be reported in a peer-reviewed journal in 2015.

TRIAL REGISTRATION NUMBER:

PROSPERO CRD42014013210.

KEYWORDS:

COMPLEMENTARY MEDICINE; NUTRITION & DIETETICS; PERINATOLOGY

PMID:
25475244
PMCID:
PMC4256605
DOI:
10.1136/bmjopen-2014-006475
[Indexed for MEDLINE]
Free PMC Article

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