The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran (AAD)

November 8, 2024 updated by: Mohammad Bagher Rahmati, Hormozgan University of Medical Sciences
The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The participants will be children aged 3 months to 3 years.The zinc group received oral zinc supplementation; 2.5 ml every 12 hours for children aged <1 year and 5 ml every 12 hours for older children; the probiotics group received oral probiotics; 1 probiotic sachet; and the control group received nothing.

Study Type

Interventional

Enrollment (Actual)

165

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Hormozgan
      • Bandar Abbas, Hormozgan, Iran, Islamic Republic of, 7915893664
        • Hormozgan University of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. children aged 3 months to 3 years
  2. prescribed antibiotics for various medical conditions

Exclusion Criteria:

  1. Diarrhea, Dysentery
  2. Underlying chronic disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 65 children in cotrol group
Only standard medication.
Experimental: 65 children in Zinc group
The zinc group received oral zinc supplementation; 2.5 ml every 12 hours for children aged <1 year and 5 ml every 12 hours for older children.
Dietary supplement: Zinc Supplement, probiotic
received oral zinc supplementation; 2.5 ml every 12 hours for children aged <1 year and 5 ml every 12 hours for older children; the probiotics group received oral probiotics; 1 probiotic sachet
Experimental: 65 children in Probiotic group
The probiotics group received oral probiotics; 1 probiotic sachet (KidiLact: Lacticaseibacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus acidophilus, Bifidobacterium bifidum and Streptococcus thermophilus)
Dietary supplement: Zinc Supplement, probiotic
received oral zinc supplementation; 2.5 ml every 12 hours for children aged <1 year and 5 ml every 12 hours for older children; the probiotics group received oral probiotics; 1 probiotic sachet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of Antibiotic-Associated Diarrhea
Time Frame: 6 month
Passing loose, watery stools three or more times a day after taking antibiotic by questionnaire.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hormozgan University of Medical Sciences

Investigators

  • Study Director: MohammadBagher Rahmati, Pediatrician, Hormozgan University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2020

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

May 1, 2021

Study Registration Dates

First Submitted

October 29, 2024

First Submitted That Met QC Criteria

October 29, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 8, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.HUMS.REC.1399.579
  • Hormozgan University (Other Identifier: Hormozgan University)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all collected IPD

IPD Sharing Time Frame

October 2024-January 2026

IPD Sharing Access Criteria

For independent reviewers.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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