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

NCT ID: NCT06540209

Last Updated: 2024-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acute Watery Diarrhea

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bacillus clausii + zinc+ ORS group

Patients received zinc supplementation with ORS and Bacillus clausii

Group Type EXPERIMENTAL

Bacillus clausii

Intervention Type DRUG

Children will be give Bacillus clausii for 5 days

Zinc

Intervention Type DRUG

Zinc will be given to all children for 5 days

ORS

Intervention Type DRUG

ORS will be given to all children for 5 days

Saccharomyces boulardii +zinc+ ORS group

Patients were given zinc with ORS and Saccharomyces boulardii

Group Type EXPERIMENTAL

Saccharomyces boulardii

Intervention Type DRUG

Children will be give Saccharomyces boulardii for 5 days

Zinc

Intervention Type DRUG

Zinc will be given to all children for 5 days

ORS

Intervention Type DRUG

ORS will be given to all children for 5 days

Interventions

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Bacillus clausii

Children will be give Bacillus clausii for 5 days

Intervention Type DRUG

Saccharomyces boulardii

Children will be give Saccharomyces boulardii for 5 days

Intervention Type DRUG

Zinc

Zinc will be given to all children for 5 days

Intervention Type DRUG

ORS

ORS will be given to all children for 5 days

Intervention Type DRUG

Other Intervention Names

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Probiotics Probiotics Standard treatment Standard treatment

Eligibility Criteria

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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
Minimum Eligible Age

3 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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RESnTEC, Institute of Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wajiha Rizwan, FCPS

Role: PRINCIPAL_INVESTIGATOR

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

Muhammad Tufail, MBBS

Role: PRINCIPAL_INVESTIGATOR

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

Azher Abbas Shah

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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University of Child Health Sciences, The Children's Hospital

Lahore, Punjab Province, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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AWD-CHLAHORE

Identifier Type: -

Identifier Source: org_study_id

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