The trial looking into treatments for acute gastroenteritis found significantly lower odds of recurrent diarrhoea in children receiving both antibiotics and Biogaia’s proprietary strain, Lactobacillus reuteri DSM 17938.
Despite the small sample size, the research team also observed a statistically significant increase in age-standardised height (HAZ) after 60 days.
The fact that L. reuteri Protectis may mitigate terrible consequences of diarrheal disease, like stunting, cognitive deficiencies and eventual adult accomplishments, and contribute to decrease in recurrent diarrhea, increased growth and improved quality of life for children in sub-Saharan countries is very encouraging,” said Axel Sjöblad, managing director of Swedish-based healthcare firm BioGaia.
Current World Health Organization (WHO) recommendations for the treatment of gastroenteritis involve prompt delivery of rehydration solutions and zinc therapy.
However, interest in the use of probiotics as adjunctive therapy for children with acute gastroenteritis, particularly with L. reuteri, bacteria that make up the normal flora in the human gastrointestinal tract.
The probiotics’ beneficial effects may be mediated through the formation of biofilms in the intestinal environment, as Lactobacillus species have been observed to do;
Biofilms formed by L. reuteri strains related to DSM 17938 have previously been shown to produce large quantities of reuterin, a molecule that can inhibit the growth of intestinal pathogens.
In the trial, 71 infants 2-60 months (median age 10.8 months) old were enrolled. All infants received standard fluid rehydration plus zinc.
The infants were then randomised to receive rapid diagnostic testing (plus targeted antimicrobial therapy if indicated) plus five drops daily of either L. reuteri Protectis or placebo for 60 days.
The infants were also randomly allocated to groups that received standard care (no diagnostic testing) plus either L. reuteri Protectis or placebo for 60 days.
As well as a significant increase in 60-day adjusted height-for-age and less recurrent diarrhoea, the rapid testing plus placebo therapy did not show any significant differences compared to standard care and placebo.
A significant effect on less recurrent diarrhoea was shown also for L. reuteri Protectis, in the group that received standard care plus L. reuteri Protectis for 60 days. The changes in length were non-significant, however.
“Previous probiotic trials have focused on outcomes such as duration of diarrhoea, which are not nearly as important as a hard outcome such as standardised height, which has been directly linked to stunting, cognitive deficiencies, and eventual adult accomplishment,” said lead investigator of the study Dr Jeffrey Pernica, associate professor at McMaster Children’s Hospital in Hamilton, Canada.
Probiotics suitable in resource-limited setting
“The combination of test-and-treat diagnostics and L. reuteri DSM 17938 was associated with 93% lower odds of recurrent diarrhoea in the 60-day follow-up period, as well as a dramatic increase in age-standardised height.”
Discussing the results’ significance, the team said the use of molecular rapid enteric diagnostics (permitting timely targeted antimicrobial therapy) and the administration of L. reuteri Protectis were both feasible in a resource-limited sub-Saharan African context.
“Children from resource-limited settings are at higher risk of longer-term neurodevelopmental sequelae or fatal outcomes resulting from diarrhoeal disease, which provides a rationale for empiric antibiotics for acute diarrhoea in high-burden settings,” the study noted.
“Resistance to the broad-spectrum antimicrobials in use currently for the treatment of many bacterial enteropathogens is a concern, so a diagnostic-driven strategy is a reasonable compromise between the unacceptable mortality and morbidity associated with untreated bacterial/protozoan gastroenteritis and the widespread development of drug resistance that could result from universal antimicrobial treatment.”
Source: PLOS One
Published online ahead of print: doi.org/10.1371/journal.pone.0185177
“Rapid enteric testing to permit targeted antimicrobial therapy, with and without Lactobacillus reuteri probiotics, for paediatric acute diarrhoeal disease in Botswana: A pilot, randomized, factorial, controlled trial.”
Authors: Jeffrey Pernica et al.