Comparison of Bacillus Clausii and Saccharomyces Boulardii for Acute Diarrhea at Day 3

Comparison of the Clinical Efficacy of Bacteria-Based Probiotics to Fungi-Based Probiotics in Acute Watery Diarrhea in Pediatric Outpatient Department

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07853846

Enrollment

Registered

2026-10-02

Start date

2026-07-02

Completion date

2027-02-02

Last updated

2026-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Watery Diarrhea

Keywords

ACUTE DIARRHEA, PROBIOTIC, FUNGAL PROBIOTIC, BACTERIAL PROBIOTIC, ACUTE WATERY DIARRHEA

Brief summary

THIS STUDY WILL BE CONDUCTED ON OPD PATIENTS IN CENTRAL PARK TEACHING HOSPITAL LAHORE TO SEE THE EFFECT OF PROBIOTICS ON DIARRHEA ALL PATIENTS INCLUDED WILL HAVE ACUTE WATERY DIARRHEA AND THE OUTCOME WILL BE CHECKED ON THE THIRD DAY OF ADMISSION

Detailed description

This study is planning to compare the clinical efficacy of bacterial ( Bacillus clausii) versus fungal (Sacchromyces boulardii) probiotic in acute watery diarrhea. A clear consensus has not been reached regarding the use of appropriate probiotic. Some pediatricians are of the opinion that bacterial probiotic are suprerior to fungal probiotics along with rehydration for improvement of diarrhea. However, others experience is that fungal probiotics are better along with rehydration for the improvement of diarrhea. A high-quality evidence basis must be established that guides the pediatrician regarding the choice of probiotic.The results of this study will help guide pediatricians to the better probiotic for the clinical improvement of acute diarrhea in our setup.

Interventions

DIETARY_SUPPLEMENTBacillus clausii

Bacillus clausii, a bacterial-based probiotic, will be administered orally at a dose of 2 billion spores twice daily for 3 days, in addition to standard diarrheal treatment. Clinical efficacy will be assessed on the 3rd day based on stool frequency and consistency.

DIETARY_SUPPLEMENTSaccharomyces boulardii

Saccharomyces boulardii, a fungal-based probiotic, will be administered orally at a dose of 250 mg twice daily for 3 days, in addition to standard diarrheal treatment. Clinical efficacy will be assessed on the 3rd day based on stool frequency and consistency.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Participants will be randomly assigned to one of two parallel treatment groups. Group A will receive Bacillus clausii and Group B will receive Saccharomyces boulardii, both in addition to standard diarrheal treatment.

Eligibility

Sex/Gender

ALL

Age

0 Months to 59 Months

Healthy volunteers

Inclusion criteria

1. Children aged 0 to 59 months 2. Acute Watery Diarrhea 3. The child's parents or caregiver understands, agrees to participate, and complies with the study protoco

Exclusion criteria

1. Patients with bloody diarrhea, severe dehydration, severe electrolyte imbalance, immunocompromised children, or malabsorption disorders and systemic illnesses (sepsis, pneumonia, urinary infections) 2. Those who have already used antibiotics or probiotics during this illness 3. Known hypersensitivity to probiotics

Design outcomes

Primary

Measure	Time frame	Description
Clinical efficacy of probiotic treatment	3 days	Clinical efficacy will be assessed on the 3rd day. A positive outcome will be defined as ≤3 episodes of stool with Bristol stool grade 5 or less. The clinical efficacy of Bacillus clausii will be compared with Saccharomyces boulardii in children with acute watery diarrhea.

Countries

Pakistan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Oct 3, 2026