Evaluating the LGG of on Acute Infectious Diarrhea in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LGG, Standart of care.
- Who it may be relevant to
- Registry conditions: Acute Infectious Diarrhoea in Children. Basic parameters: 2 years — 10 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Prospective, Randomized, Double-Blind, Open-Label Clinical Trial Evaluating the Effects of Lacticaseibacillus Rhamnosus GG on Acute Infectious Diarrhea in Children in Türkiye
Overview
Acute diarrhea due to infectious causes is a major source of morbidity in the pediatric population. Although it is generally self-limiting, acute diarrhea may lead to severe dehydration, hospitalization, and, rarely, death, particularly in young children. Numerous studies have investigated the role of probiotics and other microbiota-targeted therapies in improving the clinical course of infectious acute diarrhea. The first multicenter PROBAGE study conducted in Türkiye 15 years ago provided valuable evidence regarding the efficacy of probiotics in this context. Over the past 15 years, changes in epidemiology-especially in the post-pandemic period-have created a need for new studies evaluating the effectiveness of probiotics in acute diarrhea. The PROBAGE 2.0.1 study is designed to evaluate the efficacy of Lactobacillus rhamnosus GG in the treatment of acute infectious diarrhea in children in Türkiye. This is a multicenter, prospective, randomized, open-label, controlled clinical trial, to be conducted across seven tertiary care medical centers nationwide. A total of 480 children with acute infectious diarrhea will be enrolled. At the initial presentation, stool samples will be collected to identify rotavirus, norovirus, and adenovirus as causative pathogens. The treatment group (n = 240) will receive standard of care plus Lactobacillus rhamnosus GG (one sachet twice daily for 5 or 10 days), whereas the control group (n = 240) will receive standard of care alone. Daily monitoring of stool frequency and consistency will be documented for 10 days, by families for outpatients and by physicians and nurses for hospitalized patients. Provided that sufficient data are obtained, data analysis and publication phases will be completed.
Interventions
- Other LGG
Lacticaseibacillus rhamnosus GG 5 billion CFU, twice daily for 6 days - Other Standart of care
ORS (depends on body weight) and/or intravenous fluids
Primary outcome measures
- duration of diarrhea [Time frame: 10 days]
Secondary outcome measures (1)
- Proportion of diarrhea cases lasting >5 days [Time frame: 5 days]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07342101 · PROBAGE-V0-2025-12