An interventional study of LGG and Standart of care in Acute Infectious Diarrhoea in Children, sponsored by Eskisehir Osmangazi University. Recruiting at 3 sites in Turkey (Türkiye). Open to participants aged 2 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by Eskisehir Osmangazi University · Not applicable, Interventional, and Treatment
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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 480 is above the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →Eskisehir Osmangazi University is the lead sponsor of 153 studies on the registry; 27 are open to participants now.
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Exclusion Criteria:
LGG with standart of care
Other: LGG · Other: Standart of care
Standart of care
Other: Standart of care
Lacticaseibacillus rhamnosus GG 5 billion CFU, twice daily for 6 days
ORS (depends on body weight) and/or intravenous fluids
duration of diarrhea
Mean duration of diarrhea (in days), defined as the time from onset until the return to normal stool consistency and frequency.
Time frame: 10 days
Proportion of diarrhea cases lasting >5 days
Time frame: 5 days
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2026 (actual). Primary completion is estimated for Dec 2026, 11 months after the start.
Of 129 non-industry interventional studies with no phase under Diarrhea, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 11 months is below that.
Counting every sponsor, half of 164 studies reached it within 14 months; a quarter within 5 and three quarters within 35.
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Eskisehir Osmangazi University →