Evaluating the LGG of on Acute Infectious Diarrhea in Children

NCT07342101 | Not Yet Recruiting

• 1 other identifier: PROBAGE-V0-2025-12
• Study Type: interventional
• Target: 480
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Acute Infectious Diarrhoea in Children

Keywords

probiotic; diarrhea; LGG

Outcome Measures

Primary Outcomes (1)

• duration of diarrhea

  Mean duration of diarrhea (in days), defined as the time from onset until the return to normal stool consistency and frequency.

  10 days

Secondary Outcomes (1)

• Proportion of diarrhea cases lasting >5 days

  5 days

Study Arms (2)

Probiotic

EXPERIMENTAL

LGG with standart of care

Other: LGG; Other: Standart of care

Control

ACTIVE COMPARATOR

Standart of care

Other: Standart of care

Interventions

LGG OTHER

Lacticaseibacillus rhamnosus GG 5 billion CFU, twice daily for 6 days

Probiotic

Standart of care OTHER

ORS (depends on body weight) and/or intravenous fluids

Control; Probiotic

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Pediatrics

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: January 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share