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CompletedNCT06665503AADUpdated Nov 12, 2024

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

An interventional study of Zinc Supplement, probiotic in Antibiotic-associated Diarrhea and Diarrhea, sponsored by Hormozgan University of Medical Sciences. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 3 Months to 3 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-12.

Sponsored by Hormozgan University of Medical Sciences · Not applicable, Interventional, and Prevention

From the registry’s dates

  • Registered 4 years 1 month after the study started (first participant enrolled Sep 2020, registered Oct 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
165
Allocation
Randomized
Ages
3 Months to 3 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Antibiotic-associated Diarrhea
  • Diarrhea

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Keywords

  • antibiotic-associated diarrhea
  • children zinc, probiotics
  • zinc
  • probiotics
03

In context

Diarrhea

877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.

This study's enrollment of 165 is above the median of 137 across 738 interventional studies indexed under Diarrhea.

Browse Diarrhea studies →

Lead sponsor

Hormozgan University of Medical Sciences is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Months to 3 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. Diarrhea, Dysentery
  2. Underlying chronic disease
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
165 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • Dietary supplementZinc Supplement, probiotic

    Drug pages: 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

06

What researchers measure

Primary outcomes

  1. Rate of Antibiotic-Associated Diarrhea

    Passing loose, watery stools three or more times a day after taking antibiotic by questionnaire.

    Time frame: 6 month

07

Study locations

1 site
  • Hormozgan University of Medical Sciences
    Bandar Abbas, Hormozgan 7915893664, Iran, Islamic Republic of
08

References and documents

Individual participant data

Plan to share: Yes — all collected IPD

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: October 2024-January 2026

Access criteria: For independent reviewers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06665503
Lead sponsor
Hormozgan University of Medical Sciences
Responsible party
Mohammad Bagher Rahmati (Hormozgan University of Medical Sciences, Hormozgan University of Medical Sciences) — Principal investigator
First posted
Oct 30, 2024
Start date
Sep 1, 2020
Primary completion
Mar 1, 2021
Completion
May 1, 2021
Last update
Nov 12, 2024

Study contacts

MohammadBagher Rahmati, Pediatrician
study director · Hormozgan University of Medical Sciences

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.

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Studies of the drugs tested here: Zinc Supplement · Probiotic

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