Acute Gastroenteritis, Infectious Diarrhea
Conditions
Keywords
probiotic, acute infectious diarrhea, children, microbiota
Brief 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.
Interventions
DIETARY_SUPPLEMENTProbiotic
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.
OTHERStandard therapy
Standard management of acute infectious diarrhea consisting of oral rehydration solution with or without intravenous fluids according to clinical need.
Sponsors
Eskisehir Osmangazi University
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 6 Years
Healthy volunteers
No
Inclusion criteria
* Children aged 1-6 years * Clinical diagnosis of acute infectious diarrhea * Presentation within 24 hours of symptom onset * Mild or no dehydration * Written informed consent from parents or guardians
Exclusion criteria
* Antibiotic or probiotic use within the previous month * Moderate or severe dehydration * Malnutrition * Immunosuppression * Chronic systemic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of diarrhea | Up to 10 days | Time from randomization to last diarrheal stool |
| Proportion of children free of diarrhea at 72 hours | 72 hours after start of treatment | Proportion of children free of diarrhea at 72 hours |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of children with ongoing diarrhea | Days 1-10 | Percentage of children with diarrhea recorded daily for the first 10 days. |
Countries
Turkey (Türkiye)
Outcome results
None listed