NCT07342088

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 15, 2026

Completed
Last Updated

January 16, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

January 6, 2026

Last Update Submit

January 14, 2026

Conditions

Infectious DiarrheaAcute Gastroenteritis

Keywords

probioticacute infectious diarrheachildrenmicrobiota

Outcome Measures

Primary Outcomes (2)

  • Duration of diarrhea

    Time from randomization to last diarrheal stool

    Up to 10 days

  • Proportion of children free of diarrhea at 72 hours

    Proportion of children free of diarrhea at 72 hours

    72 hours after start of treatment

Secondary Outcomes (1)

  • Proportion of children with ongoing diarrhea

    Days 1-10

Study Arms (2)

Probiotic Group

EXPERIMENTAL

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: ProbioticOther: Standard therapy

Control group

ACTIVE COMPARATOR

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

Other: Standard therapy

Interventions

Standard therapyOTHER

Standard management of acute infectious diarrhea consisting of oral rehydration solution with or without intravenous fluids according to clinical need.

Control groupProbiotic Group
ProbioticDIETARY_SUPPLEMENT

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.

Probiotic Group

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • Antibiotic or probiotic use within the previous month
  • Moderate or severe dehydration
  • Malnutrition
  • Immunosuppression
  • Chronic systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sancaktepe Ilhan Varank Research and Training Hospital, University of Health Sciences,

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Dysentery

Interventions

ProbioticsStandard of Care

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.Dr

Study Record Dates

First Submitted

January 6, 2026

First Posted

January 15, 2026

Study Start

May 1, 2024

Primary Completion

August 31, 2024

Study Completion

April 30, 2025

Last Updated

January 16, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)