Sweet Cheeks: How Early Nutrition Affects Oral Microbiota Populations and Disease Incidence
1 other identifier
observational
15
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 17, 2013
CompletedFirst Posted
Study publicly available on registry
April 22, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedOctober 31, 2016
October 1, 2016
3.4 years
April 17, 2013
October 28, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
Infants
Infant born via vaginal delivery
Eligibility Criteria
Full term infants born via vaginal delivery
You may qualify if:
- 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.
You may not qualify if:
- 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.
- full term infant
- healthy infant
- initially breastfed by mother
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Illinois
Urbana, Illinois, 61801, United States
Biospecimen
Oral swabs of tongue and cheeks. Bacterial DNA to be extracted, no human DNA will be extracted
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kelly Swanson, PhD
UIUC
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2013
First Posted
April 22, 2013
Study Start
October 1, 2012
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
October 31, 2016
Record last verified: 2016-10