Dental CariesPhase 4NCT00638677
Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
A Phase 4 study testing Sorbitol, Xylitol + BB12 and Xylitol in people with Dental Caries and Infectious Diseases, run by University of Turku at 1 site in Finland.
Trial summary
Aims: 1. To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier. 2. Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence. Read more about this study
- Who is it for?
- Ages 1 month to 4 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Infectious Diseases
- What is being tested?
- Sorbitol, Xylitol + BB12 and Xylitol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 siteFinland
- Study dates
- Jun 2004to Aug 2012
- Phase
- Phase 4
- 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 1 month to 4 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The infant is healthy
- The family agrees to use the novel slow-release pacifier
- The infant starts to use the pacifier before the age of 3 months
Who cannot join
- The child is not healthy
Trial locations and contacts
1 site in 1 country.
About this study
Aims:
- To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier.
- Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence.
Main hypothesis:
The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.
Read the detailed description
Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. Possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. Our study aims to look at caries occurrence in infants who have received the xylitol + BB12 food supplement with a pacifier.
Recruiting of subjects to the study is completed.
- Conditions
- Dental Caries, Infectious Diseases
- Being tested
- Sorbitol, Xylitol + BB12, Xylitol
- Keywords
- Oral microbiology
- Medical subject headings
- Dental Caries, Communicable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SorbitolDietary supplement
Also called Xylitol, Bifidobacterium lactis
Sorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years
Xylitol + BB12Dietary supplement
Also called Sorbitol, Bifidobacterium lactis
Xylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years
XylitolDietary supplement
Also called Sorbitol, Bifidobacterium lactis
Xylitol+BB 12 delivery with a pacifier max until 2 years
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Sorbitol tablet Receives: Dietary Supplement: Sorbitol |
| 2 | Placebo comparator | Xylitol tablet Receives: Dietary Supplement: Xylitol |
| 3 | Active comparator | Xylitol + BB12 tablet Receives: Dietary Supplement: Xylitol + BB12 |
What is being measured
The primary outcome is the main question the study is designed to answer.
MS colonization
Measured: 2 years
Secondary outcomes (2)
Acute infectious diseases
Measured: 2 years
Caries occurrence
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2008 (estimated)
- Study startJun 2004
- Primary completionAug 2012
- Study completionAug 2012
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 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Turku
- Sponsor type
- University, hospital or other
- Collaborators
- Novonesis, Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier), Plastone Oy, Konnevesi, Finland (provides the pacifiers)
- Responsible party
- Principal investigator, Eva Soderling, University of Turku
- Investigators
- Eva M Söderling, PhD, Principal investigator, Assoc. Prof., University of Turku
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00638677
- Sponsor's protocol ID
- Pacifierstudy20/8/2003
- Other IDs
- No ISRCTN or NIH grants
- Status last verified
- Jan 2013
- First submitted
- 12 Mar 2008
- Last updated
- 8 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Taipale T, Pienihakkinen K, Alanen P, Jokela J, Soderling E. Administration of Bifidobacterium animalis subsp. lactis BB-12 in early childhood: a post-trial effect on caries occurrence at four years of age. Caries Res. 2013;47(5):364-72. doi: 10.1159/000348424. Epub 2013 Apr 5.
PubMed 23571819
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bifidobacterium Lactis BB12 and Xylitol Delivered With a Novel Slow-release Pacifier
- ClinicalTrials.gov ID
- NCT00638677
- Acronym / sponsor ID
- Pacifierstudy20/8/2003
- Conditions
- Dental Caries, Infectious Diseases
- Keywords
- Oral microbiology
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- University of TurkuUniversity, hospital or other
- Collaborators
- Novonesis, Fennobon oy, Karkkila, Finland (provides the tablets for the pacifier), Plastone Oy, Konnevesi, Finland (provides the pacifiers)
- Study start
- Jun 2004
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 19 Mar 2008 (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.
Aims:
- To develop a food supplement containing a health-promoting probiotic bacteria (B. lactis BB12) and xylitol to be administered with a novel soft, possibly occlusion-friendly pacifier.
- Test in a clinical study how feasible the method is and to study how the intervention affects caries occurrence.
Main hypothesis:
The administration of B. lactis BB12 and xylitol affects beneficially the dental health of the child.
Detailed description
Xylitol is known to reduce counts of mutans streptococci (ms) as well as mother-child transmission of ms. Possibly xylitol delivered to infants could positively influence colonization/metabolism of ms. By combining in a food supplement xylitol and B. lactis BB12 (a well known probiotic bacteria) we may be able to positively affect both gut and oral colonization, reflected in both dental and general health (solid data available on the latter aim). Though B. lactis is in wide use in baby formulas and in in vitro tests it apparently is safe for the teeth, no clinical studies have looked at effects of its administration to infants on oral health. Our study aims to look at caries occurrence in infants who have received the xylitol + BB12 food supplement with a pacifier.
Recruiting of subjects to the study is completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Dietary Supplement: SorbitolSorbitol tablet |
| 2 | Placebo comparator | Dietary Supplement: XylitolXylitol tablet |
| 3 | Active comparator | Dietary Supplement: Xylitol + BB12Xylitol + BB12 tablet |
Who may qualify
- Ages
- 1 month to 4 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- The infant is healthy
- The family agrees to use the novel slow-release pacifier
- The infant starts to use the pacifier before the age of 3 months
Key exclusion criteria (1 listed)
- The child is not healthy
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 |
|---|---|---|
| SorbitolAlso: Xylitol, Bifidobacterium lactisSorbitol tablet delivered with a slow-release pacifier starting 1 mo after delivery and lasting max 2 years | Dietary supplement | 1 |
| Xylitol + BB12Also: Sorbitol, Bifidobacterium lactisXylitol + BB12 tablet delivered with a slow-release pacifier starting 1 mo after delivery and continuing max 2 years | Dietary supplement | 3 |
| XylitolAlso: Sorbitol, Bifidobacterium lactisXylitol+BB 12 delivery with a pacifier max until 2 years | Dietary supplement | 2 |
Primary outcome
MS colonization
Time frame: 2 years
2 secondary outcomes
Acute infectious diseases
Time frame: 2 years
Caries occurrence
Time frame: 4 years
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 8 Jan 2013.
- Derived from this study: PubMed 23571819Taipale T, Pienihakkinen K, Alanen P, Jokela J, Soderling E. Administration of Bifidobacterium animalis subsp. lactis BB-12 in early childhood: a post-trial effect on caries occurrence at four years of age. Caries Res. 2013;47(5):364-72. doi: 10.1159/000348424. Epub 2013 Apr 5.
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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.
Eva M Söderling, PhD principal investigator
Assoc. Prof., 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 Phase 4 study testing Sorbitol, Xylitol + BB12 and Xylitol in people with Dental Caries and Infectious Diseases, 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 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 8 Jan 2013. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
MS colonization (time frame: 2 years). 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 NCT00638677, 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 8 Jan 2013.