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Oral Candida in Infants and Dietary Type

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01438983
First Posted: September 22, 2011
Last Update Posted: September 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Nastaran Azimi, Shahid Sadoughi University of Medical Sciences and Health Services
  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 Nastaran Azimi, Shahid Sadoughi University of Medical Sciences and Health Services:

Primary Outcome Measures:
  • mean number of candida colonies [ Time Frame: 6 months ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 24 Months   (Child)
Sexes Eligible for Study:   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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: September 18, 2011
First Posted: September 22, 2011
Last Update Posted: September 22, 2011
Last Verified: September 2011

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