Comparison of Effectiveness of Zinc Supplementation With ORS and Bacillus Clausii Versus Zinc With ORS and Saccharomyces Boulardii in Acute Watery Diarrhea in Paediatric Patients

NCT06540209 — Not applicable, Completed, 60 participants, RESnTEC, Institute of Research

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT06540209
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	60 (Actual)
Sponsor	RESnTEC, Institute of Research (Other)
Conditions	Acute Watery Diarrhea
Interventions	Bacillus clausii, Saccharomyces boulardii, Zinc, ORS (Drug)
Dates	start 2023-04-01, primary completion 2023-09-30, completion 2023-09-30, first posted 2024-08-06, last updated 2024-08-12
Locations	1 site in Pakistan

-Summary

The current study was carried out to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii among the local pediatric population presenting with acute watery diarrhea.

Expand all sections · Collapse all

+Detailed description

The results and importance of effective treatment for acute watery diarrhea in pediatric patients vary throughout the world. Previously, very limited literature was available comparing the efficacy of Bacillus clausii and Saccharomyces boulardii in acute watery diarrhea, providing mixed results. The current study aims to directly compare the effectiveness of zinc supplementation with ORS and Bacillus clausii versus zinc with ORS and Saccharomyces boulardii.

+Arms and interventions

Arm	Type	Interventions	Description
Bacillus clausii + zinc+ ORS group	Experimental	Drug: Bacillus clausii; Drug: Zinc; Drug: ORS	Patients received zinc supplementation with ORS and Bacillus clausii
Saccharomyces boulardii +zinc+ ORS group	Experimental	Drug: Saccharomyces boulardii; Drug: Zinc; Drug: ORS	Patients were given zinc with ORS and Saccharomyces boulardii

Bacillus clausii (Drug), also known as Probiotics: Children will be give Bacillus clausii for 5 days
Saccharomyces boulardii (Drug), also known as Probiotics: Children will be give Saccharomyces boulardii for 5 days
Zinc (Drug), also known as Standard treatment: Zinc will be given to all children for 5 days
ORS (Drug), also known as Standard treatment: ORS will be given to all children for 5 days

+Outcome measures

Primary outcomes

Stool frequency [5 days]: Number of stools per day
Stool consistency [5 days]: Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery

+Eligibility

Sex: All, ages: 3 Months to 5 Years

Inclusion Criteria:

* Patients of either gender
* Aged 3 months to 5 years
* With acute watery diarrhea last less fewer than 14 days
* Presenting with mild to moderate dehydration

Exclusion Criteria:

* Patients with a history of blood or pus in their stools
* History of recent antibiotic or probiotic treatment
* Patients with immunodeficiency conditions, acute systemic illnesses, or chronic diarrhea
* Patients with hypersensitivity to Bacillus clausii or Saccharomyces boulardii

+Locations (1)

Facility	City	Country	Status
University of Child Health Sciences, The Children's Hospital	Lahore, Punjab Province	Pakistan

+Investigators

Wajiha Rizwan, FCPS, Principal investigator, University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
Muhammad Tufail, MBBS, Principal investigator, University of Child Health Sciences, The Children's Hospital Lahore, Pakistan
Azher Abbas Shah, Principal investigator, University of Child Health Sciences, The Children's Hospital Lahore, Pakistan