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

NCT06665503 | Completed DMC

• 2 other identifiers: IR.HUMS.REC.1399.579Hormozgan University
• Study Type: interventional
• Target: 165
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Antibiotic-associated Diarrhea; Diarrhea

Keywords

antibiotic-associated diarrhea; children zinc, probiotics; zinc; probiotics

Outcome Measures

Primary Outcomes (1)

• Rate of Antibiotic-Associated Diarrhea

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

  6 month

Study Arms (3)

65 children in cotrol group

NO INTERVENTION

Only standard medication.

65 children in Zinc group

EXPERIMENTAL

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

65 children in Probiotic group

EXPERIMENTAL

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

Zinc Supplement, probiotic 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; 65 children in Zinc group

Eligibility Criteria

• Age: 3 Months - 3 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• children aged 3 months to 3 years
• prescribed antibiotics for various medical conditions

You may not qualify if:

• Diarrhea, Dysentery
• Underlying chronic disease

Sponsors & Collaborators

• Hormozgan University of Medical Sciences: lead

Study Sites (1)

Hormozgan University of Medical Sciences

Bandar Abbas, Hormozgan, 7915893664, Iran

Location

MeSH Terms

Conditions

Diarrhea

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• MohammadBagher Rahmati, Pediatrician

  Hormozgan University of Medical Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hormozgan University of Medical Sciences

Model Details: Randomly assigned to three groups of equal size, exclusively receiving the standard antibiotic regimen or the zinc and probiotics groups

Study Record Dates

• First Submitted: October 29, 2024
• First Posted: October 30, 2024
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: May 1, 2021
• Last Updated: November 12, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: October 2024-January 2026
• Access Criteria: For independent reviewers.

Locations

IR (1)