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

NCT ID: NCT06665503

Last Updated: 2024-11-12

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Antibiotic-associated Diarrhea Diarrhea

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomly assigned to three groups of equal size, exclusively receiving the standard antibiotic regimen or the zinc and probiotics groups
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

65 children in cotrol group

Only standard medication.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

Zinc Supplement, probiotic

Intervention Type DIETARY_SUPPLEMENT

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

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)

Group Type EXPERIMENTAL

Zinc Supplement, probiotic

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

3 Months

Maximum Eligible Age

3 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hormozgan University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammad Bagher Rahmati

Hormozgan University of Medical Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

MohammadBagher Rahmati, Pediatrician

Role: STUDY_DIRECTOR

Hormozgan University of Medical Sciences

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, Iran

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Iran

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hormozgan University

Identifier Type: OTHER

Identifier Source: secondary_id

IR.HUMS.REC.1399.579

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Zinc Supplementation in Shigella Patients
NCT00321126 COMPLETED PHASE3
Zinc Sulfate Acceptability
NCT04039828 COMPLETED NA
Therapeutic Zinc in Infant Bacterial Illness
NCT00347386 COMPLETED PHASE2/PHASE3
Zinc and Pneumonia Protocol
NCT00133432 TERMINATED PHASE3