Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months

November 2, 2026 updated by: King Edward Medical University

Comparison of the Effectiveness of Saccharomyces Boulardii CNCM I-745 and Multi-Strain Bacillus Clausii in Reducing the Frequency of Acute Watery Diarrhea in Children Aged 6 to 24 Months

Clinical Trial Summary

The goal of this clinical trial is to compare the effectiveness of Saccharomyces boulardii CNCM I-745 and multi-strain Bacillus clausii in reducing the frequency of acute watery diarrhea in children aged 6 to 24 months. The main question it aims to answer is:

- Which probiotic is more effective in reducing the daily frequency of acute watery diarrhea in children?

Researchers will compare Saccharomyces boulardii CNCM I-745 with a four-strain mixture of Bacillus clausii (O/C, SIN, N/R, T) to determine which is more effective in reducing diarrhea frequency.

Participants will:

  • Receive either Saccharomyces boulardii CNCM I-745 at a daily dose of 10 billion CFU or multi-strain Bacillus clausii at a daily dose of 4 billion CFU for 3 days.
  • Receive standard treatment for diarrhea, including oral rehydration therapy (ORS), zinc supplementation, and dietary advice.
  • Be followed for 3 days after admission, with daily recording of the frequency of diarrhea episodes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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

- Background and Rationale

Acute watery diarrhea is an important cause of morbidity among children under five years of age, particularly in resource-limited settings. In young children, ongoing fluid loss can result in dehydration and may lead to serious complications if appropriate management is delayed. The mainstay of treatment is oral rehydration therapy (ORS), zinc supplementation, continued breastfeeding, and appropriate dietary management. Probiotics have also been used as adjuncts to standard treatment, with the aim of improving clinical recovery. However, the effectiveness of probiotics may vary according to the specific microorganism and strain used.

Saccharomyces boulardii CNCM I-745 is a yeast probiotic that has been investigated for its role in pediatric acute gastroenteritis. Bacillus clausii is a spore-forming bacterial probiotic, and the four strains O/C, SIN, N/R, and T have also been used in the management of gastrointestinal disorders, including diarrhea in children. Although both preparations have been studied individually, direct comparisons between these probiotic preparations in children with acute watery diarrhea remain limited.

Differences in their biological characteristics and the limited availability of direct comparative evidence provide a rationale for evaluating these two preparations within the same clinical setting and study population. Such a comparison may contribute to a better understanding of their relative effectiveness when used alongside standard treatment.

- Study Purpose

The purpose of this study is to compare the effectiveness of *Saccharomyces boulardii* CNCM I-745 and a four-strain preparation of *Bacillus clausii* (O/C, SIN, N/R, and T) in reducing the daily frequency of acute watery diarrhea in young children.

The study focuses on the change in the frequency of diarrhea episodes during the treatment and observation period. The comparison is intended to determine whether the two probiotic preparations differ in their effectiveness when administered with standard management for acute watery diarrhea.

- Study Design and Conduct

This is a randomized, open-label clinical trial conducted in the Children Emergency and Outpatient Department of Paediatric Medicine Unit-II, King Edward Medical University / Mayo Hospital, Lahore, Pakistan.

The study plans to include 88 children, with 44 participants allocated to each treatment group. Participants will be selected using non-probability convenient sampling from children presenting to the study setting who meet the protocol-defined selection criteria. After assessment for eligibility and obtaining written informed consent from a parent or guardian, participants will be allocated to one of the two groups using a lottery method.

The study is open-label, meaning that treatment allocation is not blinded to the participants' caregivers or the study team. Both groups will receive the same general standard management for diarrhea, including oral rehydration therapy, zinc supplementation, and dietary advice. This approach allows the daily frequency of diarrhea to be compared between the two probiotic treatment groups under the same clinical setting and observation period.

- Clinical Assessment and Data Collection

At enrollment, a clinical assessment will be performed, and relevant demographic and clinical information will be recorded on the study proforma. This includes age, sex, weight, vital signs, the onset of diarrhea, and the reported frequency of diarrhea during the preceding 24 hours. Clinical assessment will also establish whether the child meets the protocol's definition of acute watery diarrhea with some dehydration.

During the study period, the frequency of diarrhea episodes will be documented daily. Participants will be followed for three days after admission, and the recorded information will be used to compare the two groups. The study will assess the daily stool frequency observed during follow-up rather than assume that one probiotic is more effective than the other.

- Data Analysis and Interpretation

Study data will be entered and analyzed using Statistical Package for the Social Sciences (SPSS), version 26. Quantitative variables, including age, weight, and stool frequency, will be summarized using means and standard deviations. The independent-samples t-test will be used for comparisons of quantitative variables as specified in the study protocol. Qualitative variables, including sex, dehydration status, and nutritional status, will be summarized as frequencies and percentages and compared using the chi-square test. A p-value of less than 0.05 will be considered statistically significant.

The findings will be interpreted by comparing the recorded diarrhea frequency between the two treatment groups. The results may help inform clinical decision-making regarding the choice of probiotic as an adjunct to standard treatment in children with acute watery diarrhea. The study is intended to provide evidence from a local pediatric clinical setting; its findings will be interpreted in the context of its sample size, study design, and follow-up period.

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 (Estimated)

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.
88

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Dr. Mimpal Singh Associate Professor, Paediatrics, MBBS, MCPS, MD, DCH, PHD, PGPN
  • Phone Number: 03334229251
  • Email: singh.ms1437@gmail.com

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

6 months to 2 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • Children aged 6 to 24 months.
  • Children of either sex.
  • Children with a clinical diagnosis of acute watery diarrhea, defined as three or more loose/liquid stools per day for less than 14 days, with some dehydration.
  • Children able to take oral medication.

Exclusion Criteria

  • Children with severe systemic illness, including immunodeficiency, sepsis, or congenital gastrointestinal anomalies.
  • Children with severe malnutrition.
  • Children who received systemic antibiotics, probiotics, or medications affecting gastrointestinal motility, including laxatives, antiemetics, antisecretory agents, adsorbent medications, or opiates, within 7 days before enrollment.
  • Children with a known allergy or hypersensitivity to either study probiotic or any of its formulation components.

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: Saccharomyces boulardii CNCM I-745

Participants assigned to this arm will receive Saccharomyces boulardii CNCM I-745 at a daily dose of 10 billion CFU (1 × 10¹⁰ CFU/day) for 3 days. Standard management, including oral rehydration solution (ORS), zinc supplementation, and dietary advice, will also be provided.
Drug: Saccharomyces boulardii CNCM I-745

Probiotic yeast preparation containing Saccharomyces boulardii CNCM I-745, administered orally at a daily dose of 10 billion colony-forming units (CFU) for 3 days.

Other Names:
  • Enflor
Experimental: Multi-strain Bacillus clausii (O/C, SIN, N/R, and T)

Participants assigned to this arm will receive multi-strain Bacillus clausii (O/C, SIN, N/R, and T) at a daily dose of 4 billion CFU (4 × 10⁹ CFU/day) for 3 days. Standard management, including oral rehydration solution (ORS), zinc supplementation, and dietary advice, will also be provided.
Drug: Bacillus clausii (O/C, SIN, N/R, T)

Four-strain probiotic preparation containing Bacillus clausii strains O/C, SIN, N/R, and T, administered orally at a daily dose of 4 billion colony-forming units (CFU) for 3 days.

Other Names:
  • Enterogermina

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
Daily frequency of diarrhea episodes
Time Frame: Day 1 through Day 3 after admission (3 days)

Number of diarrhea episodes per day, recorded daily for 3 days after admission in children aged 6-24 months receiving either Saccharomyces boulardii CNCM I-745 or multi-strain Bacillus clausii, alongside standard treatment for diarrhea.
Day 1 through Day 3 after admission (3 days)

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.
King Edward Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Dr. Aniqua Tahir, MBBS, MD Paediatrics, King Edward Medical University / Mayo Hospital Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Estimated)

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.
November 1, 2026

Primary Completion (Estimated)

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.
February 1, 2027

Study Completion (Estimated)

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.
February 1, 2027

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).
October 29, 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.
November 2, 2026

First Posted (Actual)

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.
November 6, 2026

Study Record Updates

Last Update Posted (Actual)

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.
November 6, 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.
November 2, 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.
November 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.
  • aniquatahir596

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared with other researchers because the study involves young children and the research team intends to protect participant confidentiality and privacy. The data will be used for the purposes of the planned research and reporting of study results in aggregate form.

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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