June 17, 2010 (Stockholm, Sweden) — One week of supplementation with the probiotic Lactobacillus reuteri Protectis reduced crying time in colicky babies by 74%, compared with 38% with placebo, according to a double-blind study presented here at the 43rd Annual Meeting of the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition in Istanbul, Turkey.
"The data with L reuteri are convincing and confirm, in a placebo-controlled study, our earlier data with this probiotic [Pediatrics. 2007;119:e124-e130]. We believe these results will have an impact on the treatment of infants with colic," study presenter Francesco Savino, MD, PhD, from the Department of Paediatrics, Regina Margherita Children's Hospital, University of Turin, Italy, noted in a statement issued by Swedish biotechnology firm BioGaia AB, the developer and marketer of the probiotic.
In the study, 50 infants with confirmed infantile colic were randomly assigned to L reuteri Protectis (5 drops, 108 colony forming units/day) or placebo drops for 21 consecutive days. The primary outcome was a reduction (by day 21) in average crying time to less than 3 hours per day, which is the limit of colic, Dr. Savino noted.
With L reuteri, "we saw improvement after 1 week, and at the end of the study there really was a significant effect," he told conference attendees. In addition, 84% of the L reuteri–supplemented infants reached the primary outcome by day 21, compared with 43% of infants in the placebo group (P < .05), he reported.
At baseline, median crying time per day was 370 minutes in the probiotic group and 300 minutes in the placebo group. On day 7, crying time had been reduced to 95 minutes in the L reuteri group and to 185 minutes in the placebo group (P = .082).
At the study's end (day 21), there was a significant difference in median daily crying time between the groups; it was 35 minutes in the L reuteri group and 90 minutes in the placebo group (P < .05), Dr. Savino reported.
He also noted that on days 7, 14, and 21, the proportion of infants responding to the supplementation, defined as a 50% or greater reduction in median crying time, was significantly greater in the probiotic group than in the placebo group.
In an email to Medscape Gastroenterology, Eamonn Connolly, PhD, senior vice president of research for BioGaia, in Stockholm, Sweden, said complete data from the study are scheduled to be published in a medical journal shortly.
Mechanism of Action Not Clearly Established
The effects of L reuteri noted in the study "could be due to a change in the intestinal commensal bacteria," Flavia Indrio, MD, PhD, who has studied the gastrointestinal effects of probiotics extensively, noted in an email to Medscape Gastroenterology. Dr. Indrio is a pediatric gastroenterologist in the Department of Pediatrics at the University of Bari in Italy, and was not involved in this study.
"The crying infant who received L reuteri showed a reduction in Escherichia coli in the intestinal microflora, compared with the infant treated with placebo," said Dr. Indrio.
She added that "the target of the L reuteri action could be the intestinal motility pattern, as shown in the study published by me and my coworker in the Journal of Pediatrics in 2008. Another study is running in newborns to confirm this effect."
"Definitely, treatment with probiotics could open a new therapeutic approach in some gastrointestinal diseases," Dr. Indrio concluded.
The study was sponsored by BioGaia, which develops and markets probiotic products. Dr. Savino reports being an independent investigator with no relationship with BioGaia. Dr. Indrio has disclosed no relevant financial relationships.
43rd Annual Meeting of the European Society for Pediatric Gastroenterology, Hepatology, and Nutrition. Presented June 10, 2010.
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Cite this: Probiotic Reduces Crying Time in Infants With Colic - Medscape - Jun 17, 2010.