Related Experiment Video
Updated: Nov 27, 2025
Probiotic Studies in Neonatal Mice Using Gavage
Published on: January 27, 2019
Association between Age, Weight, and Dose and Clinical Response to Probiotics in Children with Acute Gastroenteritis
David Schnadower1, Robert E Sapien2, T Charles Casper3
1Division of Emergency Medicine, Cincinnati Children's Hospital Medical Center, Department of Pediatrics, University of Cincinnati College of Medicine, Cincinnati, OH, USA.
Insights
Lactobacillus rhamnosus GG (LGG) did not improve outcomes for acute gastroenteritis (AGE) in children, irrespective of age, weight, or dosage. This study confirms LGG offers no clinical benefit for pediatric AGE.
Area of Science:
- Pediatric Gastroenterology
- Microbiome Research
- Clinical Trial Analysis
Background:
- Acute gastroenteritis (AGE) is a significant childhood illness.
- Probiotics, including Lactobacillus rhamnosus GG (LGG), are commonly used for AGE treatment.
- A prior large trial found LGG ineffective compared to placebo in children with AGE.
Purpose of the Study:
- To investigate if LGG's efficacy in treating pediatric AGE varies with patient age, weight metrics, or administered dose.
- To analyze secondary outcomes like diarrhea and vomiting frequency and duration.
Main Methods:
- Secondary analysis of a multicenter, double-blind, randomized controlled trial (RCT) involving 813 children (3-48 months) with AGE.
- Children received either LGG (1x10^10 CFU twice daily for 5 days) or placebo.
- Multivariable models assessed interactions between LGG treatment and participant factors (age, weight z-score, weight percentile, dose/kg) on primary and secondary outcomes.
Main Results:
- No significant interaction effects were observed between LGG treatment and age, adjusted weight z-score, adjusted weight percentile, or dose per kilogram for the primary outcome of moderate to severe gastroenteritis.
- A statistical association favored placebo for vomiting episodes and duration at the extremes of adjusted weight z-scores.
- No other statistically significant differences were found in secondary outcomes.
Conclusions:
- Lactobacillus rhamnosus GG (LGG) does not improve outcomes in children with acute gastroenteritis (AGE).
- Efficacy is not influenced by participant age, weight status, or probiotic dose per kilogram.
- These findings reinforce that LGG provides no clinical benefit for pediatric AGE.
Background:
Gastroenteritis is a common and impactful disease in childhood. Probiotics are often used to treat acute gastroenteritis (AGE); however, in a large multicenter randomized controlled trial (RCT) in 971 children, Lactobacillus rhamnosus GG (LGG) was no better than placebo in improving patient outcomes.
Objectives:
We sought to determine whether the effect of LGG is associated with age, weight z score and weight percentile adjusted for age and sex, or dose per kilogram administered.
Methods:
This was a preplanned secondary analysis of a multicenter double-blind RCT of LGG 1 × 1010 CFU twice daily for 5 d or placebo in children 3-48 mo of age with AGE. Our primary outcome was moderate to severe gastroenteritis. Secondary outcomes included diarrhea and vomiting frequency and duration, chronic diarrhea, and side effects. We used multivariable linear and nonlinear models testing for interaction effects to assess outcomes by age, weight z score and weight percentile adjusted for age and sex, and dose per kilogram of LGG received.
Results:
A total of 813 children (84%) were included in the analysis; 413 received placebo and 400 LGG. Baseline characteristics were similar between treatment groups. There were no differential interaction effects across ranges of age (P-interaction = 0.32), adjusted weight z score (P-interaction = 0.43), adjusted weight percentile (P-interaction = 0.45), or dose per kilogram of LGG received (P-interaction = 0.28) for the primary outcome. Whereas we found a statistical association favoring placebo at the extremes of adjusted weight z scores for the number of vomiting episodes (P-interaction = 0.02) and vomiting duration (P-interaction = 0.0475), there were no statistically significant differences in other secondary outcome measures (all P-interactions > 0.05).
Conclusions:
LGG does not improve outcomes in children with AGE regardless of the age, adjusted weight z score, and adjusted weight percentile of participants, or the probiotic dose per kilogram received. These results further strengthen the conclusions of low risk of bias clinical trials which demonstrate that LGG provides no clinical benefit in children with AGE.This trial was registered at clinicaltrials.gov as NCT01773967.
More Related Videos
08:34Investigating the Alleviating Effects of Bacillus cereus Administration on Colitis through Gut Microbiota Modulation
Published on: July 27, 2022
12:12Transformation of Probiotic Yeast and Their Recovery from Gastrointestinal Immune Tissues Following Oral Gavage in Mice
Published on: February 8, 2016
Related Concept Videos
01:23Pharmacokinetics in Pediatric Patients: Overview and Drug Absorption
01:29Drug Dosing: Infants and Children
01:21Factors Affecting Drug Response: Overview
01:30Inflammatory Bowel Disease III: Diagnostic Studies and Management I-Nutritional Therapy
Diagnostic studies
A colonoscopy is the definitive screening test, distinguishing ulcerative colitis from other colon diseases with similar symptoms. During a colonoscopy test, inflamed mucosa with exudate ulcerations can be observed, and biopsies are taken to determine the histologic characteristics of the...
01:18Drugs Affecting GI Tract Motility: Antimicrobials as Antidiarrheal Agents
01:24Pharmacokinetics in Pediatric Patients: Drug Metabolism