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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01438983
Other study ID # uni43
Secondary ID
Status Completed
Phase N/A
First received September 18, 2011
Last updated September 21, 2011
Start date July 2009
Est. completion date June 2010

Study information

Verified date September 2011
Source Shahid Sadoughi University of Medical Sciences and Health Services
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 90
Est. completion date June 2010
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Month to 24 Months
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Retrospective


Locations

Country Name City State
Iran, Islamic Republic of Nastaran Azimi Yazd

Sponsors (1)

Lead Sponsor Collaborator
Shahid Sadoughi University of Medical Sciences and Health Services

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary mean number of candida colonies number of candida colonies growth in agar plate 6 months Yes
Secondary prevalence of oral candida colonization in infants according to age and sex exist of candida colony in agar plate 6 months Yes
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