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CompletedNCT01438983Updated Sep 22, 2011

Oral Candida in Infants and Dietary Type

An observational study in Oral Candida, Breastfeeding and Bottle Feeding, sponsored by Shahid Sadoughi University of Medical Sciences and Health Services. Completed at 1 site in Iran, Islamic Republic of. Open to participants aged 1 Month to 24 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-09-22.

Sponsored by Shahid Sadoughi University of Medical Sciences and Health Services · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
90
Ages
1 Month to 24 Months
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Oral Candida
  • Breastfeeding
  • Bottle Feeding
03

In context

Candidiasis

132 studies on the registry are indexed under Candidiasis; 9 are open to participants now.

This study's enrollment of 90 is below the median of 162 across 39 observational studies indexed under Candidiasis.

Browse Candidiasis studies →

Lead sponsor

Shahid Sadoughi University of Medical Sciences and Health Services is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

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

04

Who can participate

Ages eligible
1 Month to 24 Months
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

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

  • healthy infants
  • healthy mothers

Exclusion criteria

Exclusion Criteria:

  • pacifier usage
  • use of antibiotics in last month
  • sign or symptom of oral candidiasis in infants
  • vagina and mammary candidiasis in mothers
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
90 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • breastfeeding infants
  • bottle feeding infants
06

What researchers measure

Primary outcomes

  1. mean number of candida colonies

    number of candida colonies growth in agar plate

    Time frame: 6 months

Secondary outcomes

  1. prevalence of oral candida colonization in infants according to age and sex

    exist of candida colony in agar plate

    Time frame: 6 months

07

Study locations

1 site
  • Nastaran Azimi
    Yazd, 8917638546, Iran, Islamic Republic of
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2009 and a completion of Jun 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 18, 2011
First posted
Sep 22, 2011
Start
Jul 2009
CompletionActual
Jun 2010
Last update
Sep 22, 2011
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 22, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01438983
Lead sponsor
Shahid Sadoughi University of Medical Sciences and Health Services
Responsible party
Nastaran Azimi (Principal Investigator, Shahid Sadoughi University of Medical Sciences and Health Services) — Principal investigator
First posted
Sep 22, 2011
Start date
Jul 2009
Completion
Jun 2010
Last update
Sep 22, 2011

Study contacts

nastaran azimi, dr
principal investigator · shahid sadoughi university of medical sciences and health science

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.

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