Health BehaviorNCT01836952
Sweet Cheeks: How Early Nutrition Affects Oral Microbiota Populations and Disease Incidence
An observational study of Health Behavior, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 2 days to 7 monthsHealthy volunteers can take part
- Conditions the study is for
- Health Behavior
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 days to 7 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Full term infants born via vaginal delivery
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Health Behavior
- Medical subject headings
- Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Infants | Infant born via vaginal delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: birth to 6 months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kelly Swanson, PhD, Principal investigator, UIUC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01836952
- Sponsor's protocol ID
- 11621
- Status last verified
- Oct 2016
- First submitted
- 17 Apr 2013
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sweet Cheeks: How Early Nutrition Affects Oral Microbiota Populations and Disease Incidence
- ClinicalTrials.gov ID
- NCT01836952
- Acronym / sponsor ID
- 11621
- Conditions
- Health Behavior
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 22 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants | – | –Infant born via vaginal delivery |
Who may qualify
- Ages
- 2 days to 7 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Full term infants born via vaginal delivery
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kelly Swanson, PhD principal investigator
UIUC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Health Behavior, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral Bacteria (time frame: birth to 6 months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.