Stephen B Freedman1, Philip M Sherman2, Andrew Willan3, David Johnson4, Serge Gouin5, Suzanne Schuh2. 1. Alberta Children's Hospital, Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada stephen.freedman@albertahealthservices.ca. 2. The Hospital for Sick Children, University of Toronto, Toronto, Ontario, Canada. 3. SickKids Research Institute, Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada. 4. Alberta Children's Hospital, Alberta Children's Hospital Research Institute, University of Calgary, Calgary, Alberta, Canada. 5. CHU Ste-Justine, Université de Montréal, Montreal, Quebec, Canada.
Abstract
BACKGROUND: Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown. METHODS: In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 10(9) colony forming units per day), or high-dose (8 × 10(9) colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism. RESULTS: The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI -14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose. CONCLUSIONS: The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required.
RCT Entities:
BACKGROUND: Benefits associated with probiotic administration to children seeking emergency department care with diarrheal disease are unknown. METHODS: In this 3-site, double-blind, placebo-controlled study, children aged 4 to 48 months with gastroenteritis were randomized to receive 5 days of placebo, low-dose (4 × 10(9) colony forming units per day), or high-dose (8 × 10(9) colony forming units per day) probiotic (Lactobacillus helveticus and Lactobacillus rhamnosus) in a 2:1:1 ratio. The primary outcome was day care absenteeism. RESULTS: The proportion of children missing a day of day care was 63% (39/62) and 61% (37/61) in the placebo and probiotic arms, respectively (95%CI -14.6% to 18.9%). The proportions experiencing unscheduled health care provider visits and intravenous fluid rehydration were 24% (15/62), 7% (4/62), and 30% (18/61), 5% (3/61) in the placebo and probiotic study arms, respectively (P = .52 and P = .65). None of the results differed based on probiotic dose. CONCLUSIONS: The probiotic evaluated did not reduce absenteeism. Since power was suboptimal, further evaluation is required.
Authors: Adam C Levine; Karen J O'Connell; David Schnadower; T John M VanBuren; Prashant Mahajan; Katrina F Hurley; Phillip Tarr; Cody S Olsen; Naveen Poonai; Suzanne Schuh; Elizabeth C Powell; Ken J Farion; Robert E Sapien; Cindy G Roskind; Alexander J Rogers; Seema Bhatt; Serge Gouin; Cheryl Vance; Stephen B Freedman Journal: J Pediatr Gastroenterol Nutr Date: 2022-02-03 Impact factor: 3.288
Authors: Shelui Collinson; Andrew Deans; April Padua-Zamora; Germana V Gregorio; Chao Li; Leonila F Dans; Stephen J Allen Journal: Cochrane Database Syst Rev Date: 2020-12-08
Authors: Jeffrey M Pernica; Andrew P Steenhoff; Margaret Mokomane; Banno Moorad; Kwana Lechiile; Marek Smieja; Loeto Mazhani; Ji Cheng; Matthew S Kelly; Mark Loeb; Ketil Stordal; David M Goldfarb Journal: PLoS One Date: 2017-10-09 Impact factor: 3.240