The probiotic’s extensive documentation has already gained the product several health claims from the Canadian regulatory authorities (NHPD), including: “Helps to reduce the risk of antibiotic associated diarrhea AAD (in children and adolescents from 2 to 18 years of age),” or “Restoring and maintaining intestinal flora” (Claim NPN 80020017).
The new multicentric randomized, placebo-controlled study, titled: “Impact of Emergency Department Probiotic Treatment of Pediatric Gastroenteritis: Randomized Controlled Trial” has been instigated by lead investigator Dr. Stephen Freedman of the University of Calgary and Alberta Children’s Hospital Research Institute, following a pilot study. The aim of the study is to evaluate the efficacy of LACIDOFIL in the treatment of acute gastroenteritis in children admitted to the emergency department.
Enrolment for this 3-year study will start in Canada this fall and approximately 900 children are expected to enter the study. Five Hospitals are involved: the Alberta Children’s Hospital in Calgary, the Children’s Hospital of Eastern Ontario in Ottawa, the CHU Sainte-Justine Mother and Child University Hospital Centre in Montreal, The Hospital for Sick Children in Toronto and the IWK Health Centre in Halifax. This study is supported by funding from the Canadian Institutes for Health Research.
Due to the significant burden of acute gastroenteritis, the study has already received ample interest from the media and public in Canada. Dr. Freedman said, “The goal of the study is to see if the child’s life is made better, especially during the first week after the emergency room visit. If we can do anything to get children back to school and shorten that two week period of illness, it will help ordinary families.”
Gastroenteritis is among the most common conditions that lead to children’s hospitalizations. It is caused by various viral or bacterial enteropathogens and characterized by diarrheas accompanied or not by vomiting, fever or abdominal pain. Major complications are linked to dehydratation. In the U.S., the estimated incidence rate is of 1-2.5 episodes of diarrhea per child per year, which leads to approximately 38 million cases annually, 2-3.7 million physician visits and 320,000 hospitalizations. In Canada, it represents up to up 240,000 children visits to hospitals every year. Thanks to their ability to preserve and restore the gut microflora balance and functions, probiotics have shown good potential to prevent or help reduce diarrheas.