PROBAGE 2Lactobacillus Rhamnosus GG for Acute Infectious Diarrhea in Children
This study aims to evaluate the effectiveness of Lactobacillus Rhamnosus GG as a treatment for acute infectious diarrhea in children.
LGG
+ Standart of care
Diarrhea+1
+ Signs and Symptoms
+ Signs and Symptoms, Digestive
Treatment Study
Summary
Study start date: January 1, 2026
Actual date on which the first participant was enrolled.Acute diarrhea caused by infections is a common health issue in children, sometimes leading to severe dehydration, hospitalization, or even death. While it typically resolves on its own, researchers are exploring ways to improve recovery, including the use of probiotics. A previous study in Türkiye, known as the PROBAGE study, showed promising results for probiotics in treating acute diarrhea. However, changes in disease patterns, especially post-pandemic, necessitate a fresh look at the effectiveness of probiotics. The PROBAGE 2.0.1 study aims to evaluate the benefits of Lactobacillus rhamnosus GG, a type of probiotic, in treating acute infectious diarrhea in children across Türkiye. This nationwide study involves 480 children with acute infectious diarrhea, who will be divided into two groups. One group will receive the standard care plus Lactobacillus rhamnosus GG (given in a sachet, twice daily for 5 or 10 days), while the other group will receive only the standard care. Stool samples will be collected at the start to identify the causative viruses. The frequency and consistency of stool will be monitored daily for 10 days, either by families for outpatients or by medical professionals for hospitalized children. The study hopes to gather enough data for analysis and publication, contributing to a better understanding of how probiotics can aid in the treatment of acute diarrhea in children.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.480 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 2 to 10 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: * Children aged 1 month to 10 years presenting with acute infectious diarrhea (for S. boulardii group) * Children aged 2 to 10 years presenting with acute infectious diarrhea (other probiotics or synbiotics groups) * Onset of diarrhea symptoms within the last 48 hours. * Parental/legal guardian consent obtained. Exclusion Criteria: * Use of any probiotics or biotic formulations within the past 8 weeks. * Use of antibiotics in the last 8 weeks. * Presence of chronic diseases (e.g., diabetes, congenital heart disease, immunodeficiencies). * Previous gastrointestinal surgical procedures.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
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