JAMA Pediatrics Journal Club Slides: Probiotic in Colic, Regurgitation, & Constipation

Copyright restrictions may apply

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.


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.

Introduction


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.

Methods


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.


Results

Primary Outcome at 1 Month of Life


Results

Primary Outcome at 3 Months of Life


Secondary Outcome at 3 Months of Life

Results


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.


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.


• 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.

Contact Information

JAMA Pediatrics Journal Club Slides: Probiotic in Colic, Regurgitation, & Constipation

Documents

Transcript of JAMA Pediatrics Journal Club Slides: Probiotic in Colic, Regurgitation, & Constipation