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Completed

NCT Number: NCT01438983

Oral Candida in Infants and Dietary Type

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.

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Key information

Age range

1 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Nastaran Azimi

Yazd, Yazd Province, 8917638546, Iran

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. mean number of candida colonies

    Time frame: 6 months

    number of candida colonies growth in agar plate

Secondary outcomes

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

    Time frame: 6 months

    exist of candida colony in agar plate

Sponsors and collaborators

Lead sponsor

Shahid Sadoughi University of Medical Sciences and Health Services

Other

Registry information

Official study title

Evaluation the Effect of Dietary Type on Oral Candida Carriage in Infants

Important dates

Study start
2009
Study completion
2010
First posted
Sep 22, 2011
Registry last updated
Sep 22, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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