NCT07342088

Lactobacillus Acidophilus and Limosilactobacillus Reuteri for Acute Diarrhea in Children

The Combination of Lactobacillus Acidophilus DSMZ 26280 and Limosilolactobacillus Reuteri DSMZ 25441 Has an Impact on Clinical Course and Gut Microbiota of Children With Acute Infec-tious Diarrhea

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 145 (actual)
• Sponsor: Eskisehir Osmangazi University · Academic / Other
• Sex: All
• Age: 1 Year – 6 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial evaluated the effect of a combination of Lactobacillus acidophilus DSMZ 26280 and Limosilactobacillus reuteri DSMZ 25441 on the duration of diarrhea and gut microbiota composition in children aged 1-6 years with acute infectious diarrhea.

Detailed description

This prospective, randomized, controlled, open-label clinical trial was conducted between March 2024 and August 2024 at the Pediatric Emergency Department of Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital, Istanbul, Türkiye. Children aged 1-6 years presenting within 24 hours of onset of acute infectious diarrhea were randomized 1:1 to receive standard therapy (oral rehydration solution with or without intravenous fluids) alone or in combination with a probiotic preparation containing Lactobacillus acidophilus DSMZ 26280 (1×10⁸ CFU) and Limosilactobacillus reuteri DSMZ 25441 (1×10⁸ CFU) administered once daily for 5 days. The primary outcomes were duration of diarrhea and the proportion of children who were diarrhea-free at 72 hours. Secondary outcomes included the proportion of children with diarrhea during the first 10 days of follow-up. A subgroup underwent longitudinal gut microbiota analysis at baseline, day 10, and day 30 using 16S rRNA sequencing. The study was approved by the Ethics Committee of Prof. Dr. İlhan Varank Sancaktepe Training and Research Hospital (approval date April 17, 2024; decision no: 126), and written informed consent was obtained from all parents or legal guardians.

Conditions

• Infectious Diarrhea
• Acute Gastroenteritis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	A probiotic preparation containing Lactobacillus acidophilus DSMZ 26280 (1×10⁸ CFU) and Limosilactobacillus reuteri DSMZ 25441 (1×10⁸ CFU) administered orally as drops once daily for 5 consecutive days, in addition to standard rehydration therapy.
OTHER	Standard therapy	Standard management of acute infectious diarrhea consisting of oral rehydration solution with or without intravenous fluids according to clinical need.

Timeline

• Start date: 2024-05-01
• Primary completion: 2024-08-31
• Completion: 2025-04-30
• First posted: 2026-01-15
• Last updated: 2026-01-16

Locations

1 site across 1 country: Turkey (Türkiye)