Bacterial InfectionsPhase 1/2NCT01528969
Effect of Xylitol on Oral Microbiota in Children
A Phase 1/2 study testing xylitol and sorbitol in people with Bacterial Infections, run by Kuwait University at 1 site in Kuwait.
Trial summary
1. The present controlled, randomized, doubleblind study aims to answer the following questions: How will the "normal flora" be affected by the xylitol consumption? Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci? The association of the test results will also be… Read more about this study
- Who is it for?
- Ages 11 to 14 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- xylitol and sorbitol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteKuwait
- Study dates
- Mar 2012to May 2012
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 11 to 14 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- high SM count
Who cannot join
- low SM count,
- ongoing medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts
- The present controlled, randomized, doubleblind study aims to answer the following questions:
- How will the "normal flora" be affected by the xylitol consumption?
- Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
- The association of the test results will also be compared with the caries status at the baseline.
- About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.
- Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.
- Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.
Read the detailed description
Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.
The present controlled, randomized, doubleblind study aims to answer the following questions:
- How will the "normal flora" be affected by the xylitol consumption?
- Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
- The association of the test results will also be compared with the caries status at the baseline.
After collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).
Sorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.
- Conditions
- Bacterial Infections
- Being tested
- xylitol, sorbitol
- Keywords
- oral microbiota, mutans streptococci, xylitol
- Medical subject headings
- Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
xylitolDietary supplement
Also called Xylitol chewing gum, Sorbitol chewing gum
Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day in the experimental group for a five-week period.
sorbitolDietary supplement
Also called Sorbitol chewing gum
Subjects will chew 2 pieces of sorbitol chewing gum (1,5 g/pellet) three times a day in the control group for a five-week period.
| Study group | Role | What they receive |
|---|---|---|
| Xylitol | Experimental | A half of the subjects will be randomly allocated into xylitol group. Receives: Dietary Supplement: xylitol |
| Sorbitol | Active comparator | About 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day Receives: Dietary Supplement: sorbitol |
What is being measured
The primary outcome is the main question the study is designed to answer.
MS Counts of Stimulated Saliva
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
Measured: 5 weeks
Secondary outcomes (1)
The Changes in the Counts of the 14 Other Bacterial Species
The bacterial species were measured from stimulated saliva at the beginning and after the intervention
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kuwait University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Turku, University of Michigan
- Responsible party
- Principal investigator, Eino Honkala, Kuwait University
- Investigators
- Eino Honkala, PhD, Principal investigator, Faculty of Dentistry, Kuwait University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01528969
- Sponsor's protocol ID
- DD02/10
- Other IDs
- KU-DD02/10
- Status last verified
- Jul 2015
- First submitted
- 24 Jan 2012
- Last updated
- 10 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Honkala E, Honkala S, Shyama M, Al-Mutawa SA. Field trial on caries prevention with xylitol candies among disabled school students. Caries Res. 2006;40(6):508-13. doi: 10.1159/000095650.
PubMed 17063022Honkala E, Rimpela A, Karvonen S, Rimpela M. Chewing of xylitol gum--a well adopted practice among finnish adolescents. Caries Res. 1996;30(1):34-9. doi: 10.1159/000262134.
PubMed 8850581
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Frequent Xylitol Chewing Gum Use on the Oral Microbiota in Children With High MS Counts
- ClinicalTrials.gov ID
- NCT01528969
- Acronym / sponsor ID
- DD02/10
- Conditions
- Bacterial Infections
- Keywords
- oral microbiota, mutans streptococci, xylitol
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Kuwait UniversityUniversity, hospital or other
- Collaborators
- University of Turku, University of Michigan
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 8 Feb 2012 (estimated)
- Results
- Posted 10 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- The present controlled, randomized, doubleblind study aims to answer the following questions:
- How will the "normal flora" be affected by the xylitol consumption?
- Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
- The association of the test results will also be compared with the caries status at the baseline.
- About eighty subjects with MS counts of log CFU 5 or more will be identified and invited to the study. They will be randomly divided into a Xylitol and Sorbitol group.
- Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use.
- Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general.
Detailed description
Xylitol, a 5-carbon polyol, has in clinical studies prevented caries occurrence in children and decreased counts of mutans streptococci (MS) and the amount of plaque when used on daily basis. How xylitol influences mutans streptococci is far from clear. Also the effects of xylitol on the normal flora are poorly understood.
The present controlled, randomized, doubleblind study aims to answer the following questions:
- How will the "normal flora" be affected by the xylitol consumption?
- Will daily consumption of xylitol change the plaque-saliva distribution of the mutans streptococci?
- The association of the test results will also be compared with the caries status at the baseline.
After collecting informed consent forms from the parents, about 177 children will be screened for the presence of salivary mutans streptococci (SM) with chairside test, Dentocult SM® Strip mutans (Orion Diagnostica, Finland).
Sorbitol is regarded as an inert polyol. Xylitol/Sorbitol gum (6g polyol/day) will be used for 5 weeks. Saliva samples will be collected before and after gum use. Studying and quantifying of 16 bacterial species belonging to the normal flora by DNA-DNA hybridizations and Real-time PCR will show how xylitol influenced the oral flora in general. Comparison of MS counts in unstimulated vs. stimulated saliva will show how xylitol affected the adhesivity of the MS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Xylitol | Experimental | Dietary Supplement: xylitolA half of the subjects will be randomly allocated into xylitol group. |
| Sorbitol | Active comparator | Dietary Supplement: sorbitolAbout 40 randomly allocated subjects will chew sorbitol chewing gum (1,5, g/pellet) three times a day |
Who may qualify
- Ages
- 11 to 14 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- high SM count
Key exclusion criteria (2 listed)
- low SM count,
- ongoing medication
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 |
|---|---|---|
| xylitolAlso: Xylitol chewing gum, Sorbitol chewing gumSubjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day in the experimental group for a five-week period. | Dietary supplement | Xylitol |
| sorbitolAlso: Sorbitol chewing gumSubjects will chew 2 pieces of sorbitol chewing gum (1,5 g/pellet) three times a day in the control group for a five-week period. | Dietary supplement | Sorbitol |
Primary outcome
MS Counts of Stimulated Saliva
Time frame: 5 weeks
The MS counts were measured at the beginning and in the end of the 5 weeks intervention
1 secondary outcome
The Changes in the Counts of the 14 Other Bacterial Species
Time frame: 5 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17063022Honkala E, Honkala S, Shyama M, Al-Mutawa SA. Field trial on caries prevention with xylitol candies among disabled school students. Caries Res. 2006;40(6):508-13. doi: 10.1159/000095650.
- Background: PubMed 8850581Honkala E, Rimpela A, Karvonen S, Rimpela M. Chewing of xylitol gum--a well adopted practice among finnish adolescents. Caries Res. 1996;30(1):34-9. doi: 10.1159/000262134.
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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.
Eino Honkala, PhD principal investigator
Faculty of Dentistry, Kuwait University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing xylitol and sorbitol in people with Bacterial Infections, run by Kuwait University at 1 site in Kuwait.
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 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: finished, as of the sponsor's last update on 10 Aug 2015. 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 Kuwait. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Counts of Stimulated Saliva (time frame: 5 weeks). 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 NCT01528969, which also lists 2 linked publications.
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 10 Aug 2015.