Oral Candida in Infants and Dietary Type

Breastfeeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01438983
• Other study ID #: uni43
• 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
• 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

Related Conditions & MeSH terms

• Bottle Feeding
• Breastfeeding
• Candidiasis, Oral
• Oral Candida

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