Results from a randomized, controlled pilot study in 71 infants with acute diarrhea show that rapid diagnostic testing and Lactobacillus reuteri Protectis supplementation for 60 days was associated with a significant increase in height and significantly less recurrent diarrhea compared to standard care and placebo treatment. The study, conducted in Botswana, is the first randomized probiotic trial in Southern Africa studying treatment of acute gastroenteritis.
“These results are very exciting. Our trial has shown that the administration of L. reuteri DSM 17938 shows real promise to mitigate the devastating effects of diarrheal disease in sub-Saharan Africa. Previous probiotic trials have focused on outcomes such as duration of diarrhea, which are somewhat relevant for families and clinicians, butnot nearly as important as a hard outcome such as standardized height, which has been directly linked to stunting, cognitive deficiencies, and eventual adult accomplishment. The combination of test-and-treat diagnostics and L. reuteri DSM 17938 was associated with 93% lower odds of recurrent diarrhea in the 60-day follow-up period, as well as a dramatic increase in age-standardized height”, says Associate Professor Jeffrey Pernica at McMaster Children’s Hospital in Hamilton, Canada, lead investigator of the study.
Diarrhea kills and disables children
Diarrhea is the second leading cause of mortality in the world among children under the age of five, as well as a major cause of both growth failure and impaired cognitivedevelopment. There is a clear need for improvements in diarrheal disease management in resource-limited settings.
The pilot study demonstrated that 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. These interventions led to significant increases in growth and decreases in recurrent diarrhea. The next step will be to validate these findings in a trial with a much larger number of children.
“We announced the results of this study already in October 2015 but now have the opportunity to highlight them again. 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”, says Axel Sjöblad, Managing Director, BioGaia.
The results of the study were published in PLOS ONE 9 October 2017. Study facts are found here. BioGaia announced the results already in October 2015 when the study was presented for the first time at The Infectious Disease Week in San Diego, USA.