Oral Candida in Infants and Dietary Type

NCT01438983 | Completed DMC

• 1 other identifier: uni43
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oral Candida; Breastfeeding; Bottle Feeding

Outcome Measures

Primary Outcomes (1)

• mean number of candida colonies

  number of candida colonies growth in agar plate

  6 months

Secondary Outcomes (1)

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

  6 months

Study Arms (2)

breastfeeding infants

bottle feeding infants

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• healthy infants
• healthy mothers

You may not qualify if:

• pacifier usage
• use of antibiotics in last month
• sign or symptom of oral candidiasis in infants
• vagina and mammary candidiasis in mothers

Sponsors & Collaborators

• Shahid Sadoughi University of Medical Sciences and Health Services: lead

Study Sites (1)

Nastaran Azimi

Yazd, Yazd Province, 8917638546, Iran

Location

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.

MeSH Terms

Conditions

Candidiasis; Breast Feeding; Bottle Feeding

Condition Hierarchy (Ancestors)

Mycoses; Bacterial Infections and Mycoses; Infections; Feeding Behavior; Behavior

Study Officials

• nastaran azimi, dr

  shahid sadoughi university of medical sciences and health science

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 18, 2011
• First Posted: September 22, 2011
• Study Start: July 1, 2009
• Study Completion: June 1, 2010
• Last Updated: September 22, 2011

Record last verified: 2011-09

Locations

IR (1)