Sweet Cheeks: How Early Nutrition Affects Oral Microbiota Populations and Disease Incidence

Health Behavior Clinical Trial

Official title:

Sweet Cheeks: How Early Nutrition Affects Oral Microbiota Populations and Disease Incidence

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01836952
• Other study ID #: 11621
• Status: Completed
• Phase: N/A
• First received: April 17, 2013
• Last updated: October 28, 2016
• Start date: October 2012
• Est. completion date: March 2016

Study information

• Verified date: October 2016
• Source: University of Illinois at Urbana-Champaign
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Dietary and oral hygiene habits are known to affect oral microorganisms and disease incidence, but most research has focused on preschool aged (2-4 yr old) children. A recent experiment in our lab demonstrated a highly diverse oral microbiome in the saliva of infants without teeth (3-6 months old). These data suggest that soft tissues in the mouth serve as a reservoir for pathogens and must be considered in oral health management. The evolution of microorganisms that occurs between birth and tooth eruption has not been characterized and may have great implications as it pertains to oral disease later in life. The investigators are interested in determining how dietary changes during this time affect oral microbiota. Tongue and cheek swab samples will be collected from a small cohort of infants (n=20) at 4 time points. At the same time, a survey and 3 day feeding diary of the infant's diet will be collected. In addition, a pregnancy survey and food frequency questionnaire will be administered at the time of recruitment. Research staff will conduct a 10-minute interview at the first and last oral sample collection time. These pilot data will provide important diet-oral microbe relationships in edentulous infants, allowing us to propose and test specific hypotheses pertaining to diet, oral microbes, and disease in young children.

Description:

Dietary and oral hygiene habits are known to affect oral microorganisms and disease incidence, but most research has focused on preschool aged (2-4 yr old) children. A recent experiment in our lab demonstrated a highly diverse oral microbiome in the saliva of infants without teeth (3-6 months old). These data suggest that soft tissues in the mouth serve as a reservoir for pathogens and must be considered in oral health management. The evolution of microorganisms that occurs between birth and tooth eruption has not been characterized and may have great implications as it pertains to oral disease later in life. The investigators are interested in determining how dietary changes during this time affect oral microbiota. Here, tongue and cheek swab samples will be collected from a small cohort of infants (n=20) at 4 time points: 1) within 5 days of age; 2)2 wk after infant formula feeding begins; 3) 2 wk after solid foods offered; and 4) 2 wk after breast-feeding ceases. At the same time, a survey and 3 day feeding diary of the infant's diet will be collected. In addition, a pregnancy survey and food frequency questionnaire will be administered at the time of recruitment. Research staff will conduct a 10-minute interview at the first and last oral sample collection time. These pilot data will provide important diet-oral microbe relationships in edentulous infants, allowing us to propose and test specific hypotheses pertaining to diet, oral microbes, and disease in young children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 7 Months

Eligibility

Inclusion Criteria:

• Women must deliver vaginally a full term baby (37 weeks or later). Women must have a healthy pregnancy without medical complications. Women must breastfeed their baby for a period of time after birth (greater than 1 week), followed by introduction of formula.

Exclusion criteria:

• Women must not have smoked during their pregnancy,nor have any serious medical conditions during their pregnancy.

• Infants can not be born via cesarean section.

• In addition, the infant should not have any chronic medical conditions and not taking any regular medications.

Exclusion Criteria:

• full term infant

• healthy infant

• initially breastfed by mother

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Health Behavior

Locations

Country	Name	City	State
United States	University of Illinois	Urbana	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Illinois at Urbana-Champaign

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Oral Bacteria	2 swabs of the tongue and 2 of the cheeks will be obtained at birth, 2 months of age, 4 months of age, and 6 months of age	birth to 6 months of age	No