Antibiotic-associated DiarrheaAADNCT06665503
The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran
A study testing Zinc Supplement, probiotic in people with Antibiotic-associated Diarrhea and Diarrhea, run by Hormozgan University of Medical Sciences at 1 site in Iran.
Trial summary
The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran Read more about this study
- Who is it for?
- Ages 3 months to 3 yearsHealthy volunteers can take part
- Conditions the study is for
- Antibiotic-associated Diarrhea, Diarrhea
- What is being tested?
- Zinc Supplement, probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteIran
- Study dates
- 1 Sep 2020to 1 May 2021
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 months to 3 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children aged 3 months to 3 years
- prescribed antibiotics for various medical conditions
Who cannot join
- Diarrhea, Dysentery
- Underlying chronic disease
Trial locations and contacts
1 site in 1 country.
Iran1 site
Hormozgan University of Medical Sciences
Bandar Abbas, Hormozgan, 7915893664
About this study
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.
- Conditions
- Antibiotic-associated Diarrhea, Diarrhea
- Being tested
- Zinc Supplement, probiotic
- Keywords
- antibiotic-associated diarrhea, children zinc, probiotics, zinc, probiotics
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Supplement, probioticDietary 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) Receives: Dietary Supplement: Zinc Supplement, probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Antibiotic-Associated Diarrhea
Passing loose, watery stools three or more times a day after taking antibiotic by questionnaire.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2024
- Study start1 Sep 2020
- Primary completion1 Mar 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antibiotic-associated DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomly assigned to three groups of equal size, exclusively receiving the standard antibiotic regimen or the zinc and probiotics groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hormozgan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Bagher Rahmati, Hormozgan University of Medical Sciences
- Investigators
- MohammadBagher Rahmati, Pediatrician, Study director, Hormozgan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06665503
- Sponsor's protocol ID
- IR.HUMS.REC.1399.579
- Other IDs
- Hormozgan University
- Acronym
- AAD
- Status last verified
- Oct 2024
- First submitted
- 29 Oct 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all collected IPD