Dental CariesNCT01424852
Does Administration of Probiotics During Infancy Increase the Caries Risk of a Child
A study testing Probiotics in infant milk formula in people with Dental Caries, run by University of Turku at 1 site in Finland.
Trial summary
Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy. Hypothesis: the administration of probiotics during infancy has no effect on future dental health. Read more about this study
- Who is it for?
- Ages 9 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Probiotics in infant milk formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2012to Dec 2012
- 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 9 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Child participated in the probiotic milk intervention study in early 2000
- Child lives now within 100 km from Turku
Who cannot join
- Child has a chronic illness affecting dental health
- Child lives now outside 100 km from Turku
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age
Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy.
Hypothesis: the administration of probiotics during infancy has no effect on future dental health.
- Conditions
- Dental Caries
- Being tested
- Probiotics in infant milk formula
- Keywords
- Probiotics, Caries, Oral flora
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics in infant milk formulaDietary supplement
Also called B.lactis BB12 and L.rhamnosus GG in milk formula
Probiotic infgant milk formula administered during the forst year of life
| Study group | Role | What they receive |
|---|---|---|
| Probiotics in milk formula | Active comparator | B. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy Receives: Dietary Supplement: Probiotics in infant milk formula |
| Control milk formula | Placebo comparator | The children received milk formula with no probiotics Receives: Dietary Supplement: Probiotics in infant milk formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries occurence
Measured: 10 years
Secondary outcomes (1)
Oral microbial colonization
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2011 (estimated)
- Study startJan 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Too few of the invited subjects wanted to participate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Soderling, University of Turku
- Investigators
- Erika M Isolauri, Professor, Study director, University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424852
- Sponsor's protocol ID
- Probiotics study7.4.2011
- Status last verified
- Feb 2012
- First submitted
- 26 Aug 2011
- Last updated
- 22 Feb 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Administration of Bifidobacterium Lactis BB-12 and the Caries Occurence of Children a 4 Years of Age
- ClinicalTrials.gov ID
- NCT01424852
- Acronym / sponsor ID
- Probiotics study7.4.2011
- Conditions
- Dental Caries
- Keywords
- Probiotics, Caries, Oral flora
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Too few of the invited subjects wanted to participate
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 29 Aug 2011 (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.
Aim: to examine caries occurrence in children who ten years ago received a mixture of probiotics during infancy.
Hypothesis: the administration of probiotics during infancy has no effect on future dental health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotics in milk formula | Active comparator | Dietary Supplement: Probiotics in infant milk formulaB. lactis BB-12 and L. rhamnosus GG delivered in milk formula during the first year of infancy |
| Control milk formula | Placebo comparator | Dietary Supplement: Probiotics in infant milk formulaThe children received milk formula with no probiotics |
Who may qualify
- Ages
- 9 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Child participated in the probiotic milk intervention study in early 2000
- Child lives now within 100 km from Turku
Key exclusion criteria (2 listed)
- Child has a chronic illness affecting dental health
- Child lives now outside 100 km from Turku
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 |
|---|---|---|
| Probiotics in infant milk formulaAlso: B.lactis BB12 and L.rhamnosus GG in milk formulaProbiotic infgant milk formula administered during the forst year of life | Dietary supplement | Control milk formula, Probiotics in milk formula |
Primary outcome
Caries occurence
Time frame: 10 years
1 secondary outcome
Oral microbial colonization
Time frame: 10 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2012.
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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.
Erika M Isolauri, Professor study director
University of Turku
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics in infant milk formula in people with Dental Caries, run by University of Turku at 1 site in Finland.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 22 Feb 2012. 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 Finland. 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. Some participants in this study may receive a placebo. 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 was withdrawn before enrolling participants, so there are no results.
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?
Caries occurence (time frame: 10 years). 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 22 Feb 2012.