Results Primary Outcome at 3 Months of Life

Report
JAMA Pediatrics Journal Club Slides:
Probiotic in Colic, Regurgitation, & Constipation
Indrio F, Di Mauro A, Riezzo G, et al. Prophylactic use of a
probiotic in the prevention of colic, regurgitation, and functional
constipation: a randomized clinical trial. JAMA Pediatr. Published
online January 13, 2014. doi:10.1001/jamapediatrics.2013.4367.
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Introduction
Background
• Infantile colic, gastroesophageal reflux (GER), and constipation are
common gastrointestinal disorders that lead to referral to a pediatrician
during the first 6 months of life.
• These conditions are often responsible for hospitalization, feeding
changes, use of drugs, parental anxiety, and loss of parental working days
with relevant health and social consequences.
Study Objective
• To investigate whether oral supplementation with Lactobacillus reuteri DSM
17938 during the first 3 months of life can reduce the following:
– Onset of colic, GER, and constipation in term newborns.
– Socioeconomic impact of these conditions.
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Methods
Study Design
• Multicenter, double-blind, randomized clinical trial in 589 term newborns (age
<1 week) born at 9 different neonatal units in Italy between September 1,
2010, and October 30, 2012.
Setting
• In a structured diary, parents recorded the number of episodes per day of:
– Regurgitation.
– Inconsolable crying episodes (minutes per day as already described in the
literature).
– Evacuations per day.
• Parents also recorded number of office visits, diet changes, hospitalizations,
loss of working days, and use of medications.
Patients
• 589 Infants were randomly allocated to receive L reuteri DSM 17938 or
placebo daily for 90 days.
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Methods
Outcomes
• Reduction of incidence of colic, GER, and constipation during the first 3
months of life.
• Cost-benefit analysis of probiotic supplementation.
Limitations
• Loss to follow-up of 16.8% of children enrolled in the trial.
• An unselected population was recruited, with possible risk of overtreating
healthy neonates.
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Results
Primary Outcome at 1 Month of Life
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Results
Primary Outcome at 3 Months of Life
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Results
Secondary Outcome at 3 Months of Life
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Comment
•
Daily administration of L reuteri DSM 17989 early in life decreased the
reported incidence of inconsolable crying, regurgitation, and functional
constipation in the first 3 months of life.
•
Supplementation was estimated to generate savings for families and society
(from lower utilization of health care services).
•
To our knowledge, this is the first clinical trial to address the use of a
probiotic to prevent gastrointestinal disorders in neonates.
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Comment
•
Early life events could increase visceral sensitivity and mucosal
permeability, alter the balance of the enteric microflora, and increase
mucosal and neurogenic low-grade inflammation, altering the signal of the
gut-brain-microbiota axis.
•
Driving a change of colonization during the first weeks of life through giving
lactobacilli may promote an improvement in intestinal permeability, visceral
sensitivity, and mast cell density. Probiotic administration may represent a
viable strategy for preventing gastrointestinal conditions in infants.
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Contact Information
•
If you have questions, please contact the corresponding author:
– Flavia Indrio, MD, Department of Pediatrics, Aldo Moro University
of Bari, Policlinico, Piazza G Cesare 11, Bari, Italy
([email protected]).
Funding/Support
•
This study was supported by BioGaia AB, Sweden, which provided
active study product and placebo.
Conflict of Interest Disclosures
•
None reported.
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