Oral Candida in Infants and Dietary Type

September 21, 2011 updated by: Nastaran Azimi, Shahid Sadoughi University of Medical Sciences and Health Services

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 2 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
breastfeeding infants
bottle feeding infants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
mean number of candida colonies
Time Frame: 6 months
number of candida colonies growth in agar plate
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
prevalence of oral candida colonization in infants according to age and sex
Time Frame: 6 months
exist of candida colony in agar plate
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shahid Sadoughi University of Medical Sciences and Health Services

Investigators

  • Principal Investigator: nastaran azimi, dr, shahid sadoughi university of medical sciences and health science

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

September 18, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

September 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uni43

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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