The trial will involve about 900 children, ages 3 months to 48 months, treated at St. Louis Children's and at eight other academic medical centers.
Participants may be eligible if they come to the emergency room with symptoms of gastroenteritis: watery stools, vomiting, dehydration or other signs of acute intestinal infection. They also must not have taken probiotics in the preceding two weeks and must meet other criteria.
Children will be randomly assigned to receive a probiotic or a placebo for five days. The probiotic, approved by the Food and Drug Administration, is Lactobacillus GG, or LGG, which is sold over the counter as Culturelle. Otherwise, children in the trial will receive standard clinical care.
Researchers will assess patients by tracking the severity of their gastroenteritis, taking into account the duration and frequency of diarrhea and vomiting, the duration and height of fever, and the use of health-care resources such as doctor or hospital visits and use of intravenous rehydration.
For the first five days after an emergency room visit and again at two weeks, researchers will monitor patients via symptom diaries and phone or Internet surveys. The researchers will follow up with parents at the one-, three-, six-, nine- and 12-month marks after the initial emergency room visit, to check on each child's health.
Evidence-based medicine can be an elusive goal," said co-investigator Phillip I. Tarr, MD, the Melvin E. Carnahan Professor of Pediatrics at the School of Medicine. "It is terrific that David and his emergency medicine collaborators are trying to gather high-quality data on which to base our treatment decisions."
Schnadower said investigators also will examine the impact, if any, that probiotics have on household transmission of diarrhea and a range of economic data involving missed work, missed day care and
|Contact: Elizabethe Holland Durando|
Washington University School of Medicine