Lactobacillus Acidophilus and Limosilactobacillus Reuteri for Acute Diarrhea in Children

Eskisehir Osmangazi University

Status: Completed

Conditions: Acute Gastroenteritis; Infectious Diarrhea

Treatments: Dietary Supplement: Probiotic; Other: Standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07342088

17042023126

Details and patient eligibility

About

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.

Full 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.

Enrollment: 145 patients

Sex: All

Ages: 1 to 6 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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145 participants in 2 patient groups

Probiotic Group

Experimental group

Description:

Probiotic combination of Lactobacillus acidophilus DSMZ 26280 (1×10⁸ CFU) and Limosilactobacillus reuteri DSMZ 25441 (1×10⁸ CFU), administered orally as drops once daily for 5 days, in addition to standard rehydration therapy.

Treatment:

Other: Standard therapy

Dietary Supplement: Probiotic

Control group

Active Comparator group

Description:

Standard therapy consisting of oral rehydration solution with or without intravenous fluids.

Treatment:

Other: Standard therapy