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

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ClinicalTrials.gov Identifier: NCT01836952
Recruitment Status : Completed
First Posted : April 22, 2013
Last Update Posted : October 31, 2016
Sponsor:
Information provided by (Responsible Party):
University of Illinois at Urbana-Champaign

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.

Condition or disease
Health Behavior

Detailed 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.

Study Type : Observational
Actual Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Sweet Cheeks: How Early Nutrition Affects Oral Microbiota Populations and Disease Incidence
Study Start Date : October 2012
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Group/Cohort
Infants
Infant born via vaginal delivery



Primary Outcome Measures :
  1. Oral Bacteria [ Time Frame: birth to 6 months of age ]
    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


Biospecimen Retention:   Samples With DNA
Oral swabs of tongue and cheeks. Bacterial DNA to be extracted, no human DNA will be extracted


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Ages Eligible for Study:   up to 7 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Full term infants born via vaginal delivery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01836952


Locations
United States, Illinois
University of Illinois
Urbana, Illinois, United States, 61801
Sponsors and Collaborators
University of Illinois at Urbana-Champaign
Investigators
Principal Investigator: Kelly Swanson, PhD UIUC

Responsible Party: University of Illinois at Urbana-Champaign
ClinicalTrials.gov Identifier: NCT01836952     History of Changes
Other Study ID Numbers: 11621
First Posted: April 22, 2013    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016