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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
145

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eskisehir Osmangazi University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2026

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings