Evaluating the LGG of on Acute Infectious Diarrhea in Children (PROBAGE 2)

January 6, 2026 updated by: Ener Cagri DINLEYICI, Eskisehir Osmangazi University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
LGG with standart of care
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
Active Comparator: Control
Standart of care
Other: Standart of care
ORS (depends on body weight) and/or intravenous fluids

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of diarrhea
Time Frame: 10 days
Mean duration of diarrhea (in days), defined as the time from onset until the return to normal stool consistency and frequency.
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of diarrhea cases lasting >5 days
Time Frame: 5 days
5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROBAGE-V0-2025-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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