Oral CandidaNCT01438983
Oral Candida in Infants and Dietary Type
An observational study of Oral Candida and Breastfeeding, run by Shahid Sadoughi University of Medical Sciences and Health Services at 1 site in Iran.
Trial summary
This is an observational, non-randomised trial to evaluate the effect of dietary type on infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular pediatric appointment. Read more about this study
- Who is it for?
- Ages 1 month to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Oral Candida, Breastfeeding, Bottle Feeding
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Jul 2009to Jun 2010
- Phase
- Observational
- 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 1 month to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to Yazd nikoopur clinic for regular pediatric appointment.
Who may be able to join
- healthy infants
- healthy mothers
Who cannot join
- pacifier usage
- use of antibiotics in last month
- sign or symptom of oral candidiasis in infants
- vagina and mammary candidiasis in mothers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation the Effect of Dietary Type on Oral Candida Carriage in Infants
This is an observational, non-randomised trial to evaluate the effect of dietary type on infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular pediatric appointment. Infants with unremarkable health histories, normal weight, free of sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also healthy and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and mammary candidiasis in mothers were exclusion criteria.
Read the detailed description
After filling in a questionnaire about infants dietary intake, age and sex and their mothers education level and health condition, a pre-moistened sterile cotton swab was taken from dorsal surface of tongue and mid-plate. The swabs were cultured in agar plate containing sabourauds dextrose agar medium with chloramphenicol, and kept in 37 C for 48 hours. The number of candida colonies was counted and germ tube test performed to separate candida albicans from other types. The data was collected and analyzed by SPSS software and chi-square, logistic regression and mann-whitney test. Study hypothesis: feeding by mothers milk reduces oral candida colonization.
- Conditions
- Oral Candida, Breastfeeding, Bottle Feeding
- Medical subject headings
- Candidiasis, Breast Feeding, Bottle Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| breastfeeding infants | Not described | |
| bottle feeding infants | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean number of candida colonies
number of candida colonies growth in agar plate
Measured: 6 months
Secondary outcomes (1)
prevalence of oral candida colonization in infants according to age and sex
exist of candida colony in agar plate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2011 (estimated)
- Study startJul 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CandidaStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahid Sadoughi University of Medical Sciences and Health Services
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nastaran Azimi, Shahid Sadoughi University of Medical Sciences and Health Services
- Investigators
- nastaran azimi, dr, Principal investigator, shahid sadoughi university of medical sciences and health science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01438983
- Sponsor's protocol ID
- uni43
- Status last verified
- Sep 2011
- First submitted
- 18 Sep 2011
- Last updated
- 22 Sep 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Effect of Dietary Type on Oral Candida Carriage in Infants
- ClinicalTrials.gov ID
- NCT01438983
- Acronym / sponsor ID
- uni43
- Conditions
- Oral Candida, Breastfeeding, Bottle Feeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Shahid Sadoughi University of Medical Sciences and Health ServicesUniversity, hospital or other
- Study start
- Jul 2009
- Study completion
- Jun 2010 (actual)
- First posted
- 22 Sep 2011 (estimated)
- 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.
This is an observational, non-randomised trial to evaluate the effect of dietary type on infants oral candida colonization the investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to Yazd clinic for regular pediatric appointment. Infants with unremarkable health histories, normal weight, free of sign or symptom of oral candidiasis or other mucosal disease. Their mothers were also healthy and without sign or symptom of vagina or mammary candidiasis. Pacifier usage, use of antibiotics in last months, sign or symptom of oral candidiasis in infants or vagina and mammary candidiasis in mothers were exclusion criteria.
Detailed description
After filling in a questionnaire about infants dietary intake, age and sex and their mothers education level and health condition, a pre-moistened sterile cotton swab was taken from dorsal surface of tongue and mid-plate. The swabs were cultured in agar plate containing sabourauds dextrose agar medium with chloramphenicol, and kept in 37 C for 48 hours. The number of candida colonies was counted and germ tube test performed to separate candida albicans from other types. The data was collected and analyzed by SPSS software and chi-square, logistic regression and mann-whitney test. Study hypothesis: feeding by mothers milk reduces oral candida colonization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| breastfeeding infants | – | – |
| bottle feeding infants | – | – |
Who may qualify
- Ages
- 1 month to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The investigators evaluated 90 infants in 1-24 months (45 breastfeeding and 45 bottle feeding infants) who attended to Yazd nikoopur clinic for regular pediatric appointment.
Key inclusion criteria (2 listed)
- healthy infants
- healthy mothers
Key exclusion criteria (4 listed)
- pacifier usage
- use of antibiotics in last month
- sign or symptom of oral candidiasis in infants
- vagina and mammary candidiasis in mothers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
mean number of candida colonies
Time frame: 6 months
number of candida colonies growth in agar plate
1 secondary outcome
prevalence of oral candida colonization in infants according to age and sex
Time frame: 6 months
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 22 Sep 2011.
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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.
nastaran azimi, dr principal investigator
shahid sadoughi university of medical sciences and health science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Candida and Breastfeeding, run by Shahid Sadoughi University of Medical Sciences and Health Services 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 4 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 22 Sep 2011. 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?
mean number of candida colonies (time frame: 6 months). 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 22 Sep 2011.