NCT01836952

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 31, 2016

Status Verified

October 1, 2016

Enrollment Period

3.4 years

First QC Date

April 17, 2013

Last Update Submit

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

Age2 Days - 7 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

Location

Biospecimen

Retention: SAMPLES WITH DNA

Oral swabs of tongue and cheeks. Bacterial DNA to be extracted, no human DNA will be extracted

MeSH Terms

Conditions

Health Behavior

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Kelly Swanson, PhD

    UIUC

    PRINCIPAL INVESTIGATOR

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

Locations