An interventional study of Saccharomyces boulardii CNCM I-745 and Bacillus clausii (O/C, SIN, N/R, T) in Acute Watery Diarrhea, Acute Watery Diarrhoea and Diarrhea, sponsored by King Edward Medical University. Not yet recruiting. Open to participants aged 6 Months to 24 Months. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by King Edward Medical University · Not applicable, Interventional, and Treatment
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:
- 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.
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 88 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →King Edward Medical University is the lead sponsor of 82 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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)
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.
Also known as: Enflor
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.
Also known as: Enterogermina
Daily frequency of diarrhea episodes
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.
Time frame: Day 1 through Day 3 after admission (3 days)
No study locations are listed for this record.
Plan to share: No — 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.
Start is estimated for Nov 2026; primary completion for Feb 2027, 3 months later.
Of 129 non-industry interventional studies with no phase under Diarrhea, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 3 months is below that.
Counting every sponsor, half of 164 studies reached it within 14 months; a quarter within 5 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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King Edward Medical University