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Lactobacillus reuteri DSM 17938 for managing infant colic: protocol for an individual participant data meta-analysis
Valerie Sung1, Michael D Cabana2, Frank D'Amico3
1Murdoch Childrens Research Institute, Royal Children's Hospital, The University of Melbourne, Melbourne, Victoria, Australia.
Insights
This study investigates if Lactobacillus reuteri DSM 17938 probiotic helps infant colic. The individual participant data meta-analysis aims to determine effectiveness and subgroup benefits for crying infants.
Area of Science:
- Pediatrics
- Microbiology
- Gastroenterology
Background:
- Infant colic, characterized by excessive crying in infants under 3 months, lacks a clear cause and consistent management strategies.
- Emerging research suggests a connection between infant gut microbiota and colic, positioning probiotics as a potential therapeutic avenue.
- Current evidence on probiotic efficacy for infant colic is limited and often conflicting, necessitating further investigation into specific strains and infant subgroups.
Purpose of the Study:
- To evaluate the effectiveness of the probiotic Lactobacillus reuteri DSM 17938 in managing infant colic.
- To determine if the probiotic's effects vary based on feeding method (breast, formula, combined), proton pump inhibitor use, or antibiotic exposure.
- To identify specific infant subgroups that may benefit from Lactobacillus reuteri DSM 17938 treatment.
Main Methods:
- An individual participant data meta-analysis (IPDMA) will be conducted.
- Multilevel generalized linear mixed-effects regression models will analyze individual participant data, accounting for participant nesting within studies.
- Subgroup analyses will explore variations in treatment effects based on participant and intervention characteristics.
Main Results:
- Primary outcomes include infant crying duration and treatment success (≥50% reduction in crying) at 21 days post-intervention.
- Data from all included studies will be modeled simultaneously to provide robust findings.
- The analysis will identify if Lactobacillus reuteri DSM 17938 demonstrates significant efficacy in reducing infant colic symptoms.
Conclusions:
- The study aims to provide clear evidence on the efficacy of Lactobacillus reuteri DSM 17938 for infant colic.
- Findings will help elucidate whether specific infant characteristics influence probiotic treatment outcomes.
- This research seeks to inform clinical practice regarding probiotic use in managing infant colic.
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.
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