Clinical trial Recruiting at 3 sites Interventional Ages 2 to 10

See if LGG helps kids with acute infectious diarrhea

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

Run by Eskisehir Osmangazi University · NCT07342101 · Data updated 2026-11-12

This study tests whether Lactobacillus rhamnosus GG (LGG) helps children with acute infectious diarrhea compared to standard care.

Quick facts

Study typeInterventional
Ages2 Years to 10 Years
SexAll
Enrollment480 (estimated)
SponsorEskisehir Osmangazi University
Academic / other
Locations3 sites (Eskişehir and 2 other locations)
StatusRecruiting
StartedJanuary 1, 2026
Main results expectedDecember 31, 2026
Study endsDecember 31, 2027
Registry record updatedSeptember 11, 2026
Trial IDNCT07342101 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Children aged 1 month to 10 years with acute infectious diarrhea onset within 48 hours.

Probably not a fit

Children with recent probiotic or antibiotic use, chronic diseases, or prior GI surgery may not benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter, prospective, randomized trial in Türkiye will compare LGG plus standard care to standard care alone for children with acute infectious diarrhea. Participants are recruited from several hospitals and must have diarrheal symptoms starting within 48 hours. The study includes groups receiving LGG, other probiotics or synbiotics, or standard care, with open-label design. The aim is to determine if LGG can shorten illness duration, reduce dehydration, or lessen hospitalizations. Enrollment considers age ranges and excludes recent probiotic use, recent antibiotics, and certain chronic conditions.

Why it matters

Potential benefit: If successful, LGG could shorten illness duration and reduce complications in children with infectious diarrhea.

How similar studies have gone: Previous PROBAGE studies in Türkiye showed some evidence for probiotics; this study seeks to confirm and update those findings with current epidemiology.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • Eskisehir Osmangazi University Faculty of Medicine
    Eskişehir, Turkey (Türkiye)
    Recruiting
  • Prof.Dr. Cemil Taşçıoğlu City Hospital
    Istanbul, Turkey (Türkiye)
    Recruiting
  • Sisli Hamidiye Etfal Training and Research Hospital
    Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.