Lactobacillus Acidophilus and Limosilactobacillus Reuteri for Acute Diarrhea in Children

January 14, 2026 updated by: Ener Cagri DINLEYICI, Eskisehir Osmangazi University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

145

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Sancaktepe Ilhan Varank Research and Training Hospital, University of Health Sciences,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic Group
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.
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.
Active Comparator: Control group
Standard therapy consisting of oral rehydration solution with or without intravenous fluids.
Other: Standard therapy
Standard management of acute infectious diarrhea consisting of oral rehydration solution with or without intravenous fluids according to clinical need.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of diarrhea
Time Frame: Up to 10 days
Time from randomization to last diarrheal stool
Up to 10 days
Proportion of children free of diarrhea at 72 hours
Time Frame: 72 hours after start of treatment
Proportion of children free of diarrhea at 72 hours
72 hours after start of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of children with ongoing diarrhea
Time Frame: Days 1-10
Percentage of children with diarrhea recorded daily for the first 10 days.
Days 1-10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eskisehir Osmangazi University

Collaborators

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Actual)

August 31, 2024

Study Completion (Actual)

April 30, 2025

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Estimated)

January 15, 2026

Study Record Updates

Last Update Posted (Estimated)

January 16, 2026

Last Update Submitted That Met QC Criteria

January 14, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17042023126

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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