- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01836952
Sweet Cheeks: How Early Nutrition Affects Oral Microbiota Populations and Disease Incidence
October 28, 2016 updated by: University of Illinois at Urbana-Champaign
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.
Study Overview
Status
Completed
Conditions
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
Enrollment (Actual)
15
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Urbana, Illinois, United States, 61801
- University of Illinois
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 days to 7 months (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Full term infants born via vaginal delivery
Description
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
---|
Infants
Infant born via vaginal delivery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
birth to 6 months of age
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
April 17, 2013
First Submitted That Met QC Criteria
April 19, 2013
First Posted (Estimate)
April 22, 2013
Study Record Updates
Last Update Posted (Estimate)
October 31, 2016
Last Update Submitted That Met QC Criteria
October 28, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 11621
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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