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 | Completed

• 1 other identifier: AWD-CHLAHORE
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Watery Diarrhea

Outcome Measures

Primary Outcomes (2)

• Stool frequency

  Number of stools per day

  5 days

• Stool consistency

  Graded on a five-point scale as firm, soft, thick liquid, opaque watery, and watery

  5 days

Study Arms (2)

Bacillus clausii + zinc+ ORS group

EXPERIMENTAL

Patients received zinc supplementation with ORS and Bacillus clausii

Drug: Bacillus clausii; Drug: Zinc; Drug: ORS

Saccharomyces boulardii +zinc+ ORS group

EXPERIMENTAL

Patients were given zinc with ORS and Saccharomyces boulardii

Drug: Saccharomyces boulardii; Drug: Zinc; Drug: ORS

Interventions

Bacillus clausii DRUG

Children will be give Bacillus clausii for 5 days

Also known as: Probiotics

Bacillus clausii + zinc+ ORS group

Saccharomyces boulardii DRUG

Children will be give Saccharomyces boulardii for 5 days

Also known as: Probiotics

Saccharomyces boulardii +zinc+ ORS group

Zinc DRUG

Zinc will be given to all children for 5 days

Also known as: Standard treatment

Bacillus clausii + zinc+ ORS group; Saccharomyces boulardii +zinc+ ORS group

ORS DRUG

ORS will be given to all children for 5 days

Also known as: Standard treatment

Bacillus clausii + zinc+ ORS group; Saccharomyces boulardii +zinc+ ORS group

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RESnTEC, Institute of Research: lead

Study Sites (1)

University of Child Health Sciences, The Children's Hospital

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Interventions

clausin peptide, Bacillus clausii; Probiotics; Zinc; ORALIT

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• Wajiha Rizwan, FCPS

  University of Child Health Sciences, The Children's Hospital Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

• Muhammad Tufail, MBBS

  University of Child Health Sciences, The Children's Hospital Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

• Azher Abbas Shah

  University of Child Health Sciences, The Children's Hospital Lahore, Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 6, 2024
• Study Start: April 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)