Completed

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

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What is being collected

Data Collection

Collected from today forward - Prospective
DNA Samples
Who is being recruted

Behavior

+ Health Behavior

See all eligibility criteria
How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.
Observational
Study Start: October 2012
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Summary

Principal SponsorUniversity of Illinois at Urbana-Champaign
Last updated: October 31, 2016
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Study start date: October 1, 2012

Actual date on which the first participant was enrolled.

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.

Principal SponsorUniversity of Illinois at Urbana-Champaign
Last updated: October 31, 2016
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

15 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.


Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

BehaviorHealth Behavior

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Illinois

Urbana, United StatesOpen University of Illinois in Google Maps
CompletedOne Study Center