Changes in the Oral MicrobiotaNCT02306980
Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota
A study testing Colostrum in people with Changes in the Oral Microbiota, run by University of California, Davis at 1 site in United States.
Trial summary
Oropharyngeal administration of mother's colostrum to premature infants has been proposed as a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and sepsis, particularly in intubated babies. Read more about this study
- Who is it for?
- Ages 12 hours to 7 days
- Conditions the study is for
- Changes in the Oral Microbiota
- What is being tested?
- Colostrum
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2013to Jun 2016
- Phase
- Interventional
- 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 12 hours to 7 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- premature infant with birth weight < 1500
- intubated in the first 48 hours of life
- available maternal colostrum
Who cannot join
- lethal condition
Trial locations and contacts
1 site in 1 country.
United States1 site
UC Davis Children's Hospital
Sacramento, California, 95817
About this study
Oropharyngeal administration of mother's colostrum to premature infants has been proposed as a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and sepsis, particularly in intubated babies. We propose to study the impact of this intervention on the composition of the oral microbiota.
- Conditions
- Changes in the Oral Microbiota
- Being tested
- Colostrum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ColostrumOther
Mother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours.
| Study group | Role | What they receive |
|---|---|---|
| Colostrum | Experimental | Colostrum administration Receives: Other: Colostrum |
| Control | No intervention | Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral microbiota
Changes in the composition of the community of microbes inhabiting the oral-cavity after administration of oropharyngeal maternal colostrum.
Measured: Difference between enrollment, 48 hours and 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2014 (estimated)
- Study startOct 2013
- Primary completionApr 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Changes in the Oral MicrobiotaStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark A Underwood, MD, Principal investigator, UC Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02306980
- Sponsor's protocol ID
- 531791
- Status last verified
- Jul 2017
- First submitted
- 1 Dec 2014
- Last updated
- 25 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Sohn K, Kalanetra KM, Mills DA, Underwood MA. Buccal administration of human colostrum: impact on the oral microbiota of premature infants. J Perinatol. 2016 Feb;36(2):106-11. doi: 10.1038/jp.2015.157. Epub 2015 Dec 10.
PubMed 26658119
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota
- ClinicalTrials.gov ID
- NCT02306980
- Acronym / sponsor ID
- 531791
- Conditions
- Changes in the Oral Microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 3 Dec 2014 (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.
Oropharyngeal administration of mother's colostrum to premature infants has been proposed as a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and sepsis, particularly in intubated babies. We propose to study the impact of this intervention on the composition of the oral microbiota.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colostrum | Experimental | Other: ColostrumColostrum administration |
| Control | No intervention | –Routine care |
Who may qualify
- Ages
- 12 hours to 7 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- premature infant with birth weight < 1500
- intubated in the first 48 hours of life
- available maternal colostrum
Key exclusion criteria (1 listed)
- lethal condition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ColostrumMother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours. | Other | Colostrum |
Primary outcome
Oral microbiota
Time frame: Difference between enrollment, 48 hours and 96 hours
Changes in the composition of the community of microbes inhabiting the oral-cavity after administration of oropharyngeal maternal colostrum.
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 25 Jul 2017.
- Derived from this study: PubMed 26658119Sohn K, Kalanetra KM, Mills DA, Underwood MA. Buccal administration of human colostrum: impact on the oral microbiota of premature infants. J Perinatol. 2016 Feb;36(2):106-11. doi: 10.1038/jp.2015.157. Epub 2015 Dec 10.
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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.
Mark A Underwood, MD principal investigator
UC Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colostrum in people with Changes in the Oral Microbiota, run by University of California, Davis 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 3 inclusion and 1 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 25 Jul 2017. 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 microbiota (time frame: Difference between enrollment, 48 hours and 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02306980, which also lists 1 linked publication.
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 25 Jul 2017.