Oral Candida in Infants and Dietary Type

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nastaran Azimi, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier:
NCT01438983
First received: September 18, 2011
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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.


Condition
Oral Candida
Breastfeeding
Bottle Feeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluation the Effect of Dietary Type on Oral Candida Carriage in Infants

Resource links provided by NLM:


Further study details as provided by Shahid Sadoughi University of Medical Sciences and Health Services:

Primary Outcome Measures:
  • mean number of candida colonies [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    number of candida colonies growth in agar plate


Secondary Outcome Measures:
  • prevalence of oral candida colonization in infants according to age and sex [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    exist of candida colony in agar plate


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 90
Study Start Date: July 2009
Study Completion Date: June 2010
Groups/Cohorts
breastfeeding infants
bottle feeding infants

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.

  Eligibility

Ages Eligible for Study:   1 Month to 24 Months
Genders Eligible for Study:   Both
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.

Criteria

Inclusion Criteria:

  • healthy infants
  • healthy mothers

Exclusion Criteria:

  • pacifier usage
  • use of antibiotics in last month
  • sign or symptom of oral candidiasis in infants
  • vagina and mammary candidiasis in mothers
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01438983

Locations
Iran, Islamic Republic of
Nastaran Azimi
Yazd, Iran, Islamic Republic of, 8917638546
Sponsors and Collaborators
Shahid Sadoughi University of Medical Sciences and Health Services
Investigators
Principal Investigator: nastaran azimi, dr shahid sadoughi university of medical sciences and health science
  More Information

No publications provided

Responsible Party: Nastaran Azimi, Principal Investigator, Shahid Sadoughi University of Medical Sciences and Health Services
ClinicalTrials.gov Identifier: NCT01438983     History of Changes
Other Study ID Numbers: uni43
Study First Received: September 18, 2011
Last Updated: September 21, 2011
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Candidiasis, Oral
Candidiasis
Mycoses
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on April 15, 2014