Among children under age 5 years with acute gastroenteritis, Lactobacillus reuteri DSM 17938 as an adjunct to rehydration therapy did not reduce the duration of diarrhea compared with placebo, although it did reduce the duration of hospitalization, according to a study published in The Pediatric Infectious Disease Journal.
Therefore researchers conducted a randomized, double-blind, placebo-controlled trial to assess the efficacy of L reuteri for the treatment of children under age 5 years with acute gastroenteritis. Researchers defined acute diarrhea as stool consistency changing to loose or liquid form, and/or increase of evacuation frequency to 3 or more per 24 hours. In addition, only children with diarrhea lasting for a maximum of 5 days were included.
A total of 100 children recruited from the pediatrics department of a Polish hospital met the inclusion criteria, and were randomly assigned to receive either 5 days of L reuteri in a 2×10⁸ colony-forming units dose or placebo, in addition to standard rehydration therapy. The primary study outcome was the duration of diarrhea, and secondary outcomes were the need for and duration of intravenous rehydration, use of concomitant medications, the need for hospitalization of outpatients, the duration of hospitalization, severity of diarrhea according to the modified Vesikari Scale, vomiting, diarrhea recurrence, the numbers of watery stools, and adverse events (whether they were related to the study products).
Of these 100 children, 91 were included in the intention-to-treat analysis (L reuteri, n=44; placebo, n=47). Diarrhea duration was similar in both groups (mean difference 8.3 hours; 95% CI, -17.8 to 22; P =.6), as was the occurrence of all secondary outcome measures, with the exception of the duration of hospitalization. Compared with the placebo group, the L reuteri group experienced a shorter length of stay (mean difference 6.1 hours; 95% CI, 0.1–17.7; P =.048).
Study investigators concluded that compared to placebo, L reuteri, as an adjunct to rehydration therapy, did not reduce the duration of diarrhea. Researchers highlighted that, “L reuteri reduced the duration of hospitalization [but] had no effect on other diarrhea-related outcomes. Our findings, together with those of other recently published null studies on use of probiotics in this population are important for the updating of recommendations on the use of probiotics for the management of [acute gastroenteritis] in children.”
One author reports having served as a speaker for BioGaia, the maker of L reuteri DSM 17938.
Szymański H, Szajewska H. Lack of efficacy of Lactobacillus reuteri DSM 17938 for the treatment of acute gastroenteritis: a randomized controlled trial [published online April 25, 2019]. Pediatr Infect Dis J. doi: 10.1097/INF.0000000000002355