Infectious DiarrheaNCT07342088
Lactobacillus Acidophilus and Limosilactobacillus Reuteri for Acute Diarrhea in Children
A study testing Probiotic and Standard therapy in people with Infectious Diarrhea and Acute Gastroenteritis, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 1 year to 6 years
- Conditions the study is for
- Infectious Diarrhea, Acute Gastroenteritis
- What is being tested?
- Probiotic and Standard therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 145 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- Antibiotic or probiotic use within the previous month
- Moderate or severe dehydration
- Malnutrition
- Immunosuppression
- Chronic systemic disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sancaktepe Ilhan Varank Research and Training Hospital, University of Health Sciences,
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Infectious Diarrhea, Acute Gastroenteritis
- Being tested
- Probiotic, Standard therapy
- Keywords
- probiotic, acute infectious diarrhea, children, microbiota
- Medical subject headings
- Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Standard therapyOther
Standard management of acute infectious diarrhea consisting of oral rehydration solution with or without intravenous fluids according to clinical need.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Probiotic; Other: Standard therapy |
| Control group | Active comparator | Standard therapy consisting of oral rehydration solution with or without intravenous fluids. Receives: Other: Standard therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of diarrhea
Time from randomization to last diarrheal stool
Measured: Up to 10 days
Proportion of children free of diarrhea at 72 hours
Proportion of children free of diarrhea at 72 hours
Measured: 72 hours after start of treatment
Secondary outcomes (1)
Proportion of children with ongoing diarrhea
Percentage of children with diarrhea recorded daily for the first 10 days.
Measured: Days 1-10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start1 May 2024
- Primary completion31 Aug 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infectious DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 145 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Collaborators
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Responsible party
- Principal investigator, Ener Cagri DINLEYICI, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07342088
- Sponsor's protocol ID
- 17042023126
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 16 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07342088
- Acronym / sponsor ID
- 17042023126
- Conditions
- Infectious Diarrhea, Acute Gastroenteritis
- Keywords
- probiotic, acute infectious diarrhea, children, microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 145 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Collaborators
- Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Group | Experimental | Dietary Supplement: Probiotic, Other: Standard therapyProbiotic 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. |
| Control group | Active comparator | Other: Standard therapyStandard therapy consisting of oral rehydration solution with or without intravenous fluids. |
Who may qualify
- Ages
- 1 year to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- Antibiotic or probiotic use within the previous month
- Moderate or severe dehydration
- Malnutrition
- Immunosuppression
- Chronic systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticA 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. | Dietary supplement | Probiotic Group |
| Standard therapyStandard management of acute infectious diarrhea consisting of oral rehydration solution with or without intravenous fluids according to clinical need. | Other | Control group, Probiotic Group |
Primary outcome
Duration of diarrhea
Time frame: Up to 10 days
Time from randomization to last diarrheal stool
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
1 secondary outcome
Proportion of children with ongoing diarrhea
Time frame: Days 1-10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic and Standard therapy in people with Infectious Diarrhea and Acute Gastroenteritis, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Duration of diarrhea (time frame: Up to 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2026.