Acute Infectious Diarrhoea in ChildrenPROBAGE 2NCT07342101
Evaluating the LGG of on Acute Infectious Diarrhea in Children
A study testing LGG and Standart of care in people with Acute Infectious Diarrhoea in Children, run by Eskisehir Osmangazi University at 3 sites in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 2 to 10 years
- Conditions the study is for
- Acute Infectious Diarrhoea in Children
- What is being tested?
- LGG and Standart of care
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 3 sitesTurkey (Türkiye)
- Study dates
- 1 Jan 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)3 sites, 3 recruiting
- Recruiting
Eskisehir Osmangazi University Faculty of Medicine
Eskişehir
Ayben Leblebici, 009022223922979, aybenleblebici@gmail.com
- Recruiting
Prof.Dr. Cemil Taşçıoğlu City Hospital
Istanbul
Vefik Arıca, 00902123145555, vefikarica@hotmail.com
- Recruiting
Sisli Hamidiye Etfal Training and Research Hospital
Istanbul
Nazan Dalgic, +90 212 373 50 00, nazandalgic@gmail.com
About this study
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
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.
Read more
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.
- Conditions
- Acute Infectious Diarrhoea in Children
- Being tested
- LGG, Standart of care
- Keywords
- probiotic, diarrhea, LGG
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LGGOther
Lacticaseibacillus rhamnosus GG 5 billion CFU, twice daily for 6 days
Standart of careOther
ORS (depends on body weight) and/or intravenous fluids
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | LGG with standart of care Receives: Other: LGG; Other: Standart of care |
| Control | Active comparator | Standart of care Receives: Other: Standart of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of diarrhea
Mean duration of diarrhea (in days), defined as the time from onset until the return to normal stool consistency and frequency.
Measured: 10 days
Secondary outcomes (1)
Proportion of diarrhea cases lasting >5 days
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 Jan 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Infectious Diarrhoea in ChildrenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ener Cagri DINLEYICI, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342101
- Sponsor's protocol ID
- PROBAGE-V0-2025-12
- Acronym
- PROBAGE 2
- Status last verified
- Dec 2025
- First submitted
- 6 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07342101
- Acronym / sponsor ID
- PROBAGE 2 / PROBAGE-V0-2025-12
- Conditions
- Acute Infectious Diarrhoea in Children
- Keywords
- probiotic, diarrhea, LGG
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Other: LGG, Other: Standart of careLGG with standart of care |
| Control | Active comparator | Other: Standart of careStandart of care |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LGGLacticaseibacillus rhamnosus GG 5 billion CFU, twice daily for 6 days | Other | Probiotic |
| Standart of careORS (depends on body weight) and/or intravenous fluids | Other | Control, Probiotic |
Primary outcome
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.
1 secondary outcome
Proportion of diarrhea cases lasting >5 days
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LGG and Standart of care in people with Acute Infectious Diarrhoea in Children, run by Eskisehir Osmangazi University at 3 sites in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ener C Dinleyici (00902222392979 ext. 2722, enercagri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
duration of diarrhea (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.