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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran
- ClinicalTrials.gov ID
- NCT06665503
- Acronym / sponsor ID
- AAD / IR.HUMS.REC.1399.579
- Conditions
- Antibiotic-associated Diarrhea, Diarrhea
- Keywords
- antibiotic-associated diarrhea, children zinc, probiotics, zinc, probiotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Hormozgan University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 30 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Impact of Zinc and Probiotics in Preventing Pediatric Antibiotic-Associated Diarrhea in Southern Iran
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Randomly assigned to three groups of equal size, exclusively receiving the standard antibiotic regimen or the zinc and probiotics groups
| Arm | Type | Receives |
|---|---|---|
| 65 children in cotrol group | No intervention | –Only standard medication. |
| 65 children in Zinc group | Experimental | Dietary Supplement: Zinc Supplement, probioticThe 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. |
| 65 children in Probiotic group | Experimental | Dietary Supplement: Zinc Supplement, probioticThe probiotics group received oral probiotics; 1 probiotic sachet (KidiLact: Lacticaseibacillus rhamnosus, Lactobacillus reuteri, Lactobacillus acidophilus, Bifidobacterium infantis, Lactobacillus acidophilus, Bifidobacterium bifidum and Streptococcus thermophilus) |
Who may qualify
- Ages
- 3 months to 3 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- children aged 3 months to 3 years
- prescribed antibiotics for various medical conditions
Key exclusion criteria (2 listed)
- Diarrhea, Dysentery
- Underlying chronic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Supplement, probioticreceived 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 | Dietary supplement | 65 children in Probiotic group, 65 children in Zinc group |
Primary outcome
Rate of Antibiotic-Associated Diarrhea
Time frame: 6 month
Passing loose, watery stools three or more times a day after taking antibiotic by questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Yes. all collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MohammadBagher Rahmati, Pediatrician study director
Hormozgan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Antibiotic-Associated Diarrhea (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.