CandidiasisNCT02391532
Effect of Probiotic Bacteria on Oral Candida in Frail Elderly
A study testing L. reuteri DSM 17938/ATCC PTA in people with Candidiasis, run by University of Copenhagen.
Trial summary
The aim of this study is to investigate the effect of daily intake of the probiotic Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in nursery homes. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Candidiasis
- What is being tested?
- L. reuteri DSM 17938/ATCC PTA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 215 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jun 2015
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- non-smoking
- ability to cooperate with a dental examination and saliva sampling
Who cannot join
- severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs
- severe dementia or cognitive impairment
About this study
Official title: Effect of Probiotic Bacteria (L. Reuteri) on Oral Candida Counts in Frail Elderly
The aim of this study is to investigate the effect of daily intake of the probiotic Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in nursery homes.
Read the detailed description
The aim of the present study was to investigate the effect of a twice daily intake of lozenges containing probiotic Lactobacillus reuteri on the prevalence and counts of oral Candida in senior residents living in nursery homes. The material consists of 215 elderly persons (range 60 to 102 years) living in 20 different nursery homes in the County of Kronoberg, situated in the southern parts of Sweden. The subjects were consecutively enrolled after informed consent consisting of verbal and written information directed to the individual as well as to their relatives. The study employed a double-blind randomized placebo-controlled design.
- Conditions
- Candidiasis
- Being tested
- L. reuteri DSM 17938/ATCC PTA, Placebo
- Medical subject headings
- Candidiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteri DSM 17938/ATCC PTADietary supplement
Ingestion of active lozenge twice daily for 12 weeks
PlaceboDietary supplement
Ingestion of placebo lozenge twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri DSM 17938/ATCC PTA | Active comparator | L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks Receives: Dietary Supplement: L. reuteri DSM 17938/ATCC PTA |
| Placebo | Placebo comparator | Placebo lozenges twice daily for 12 weeks Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of oral Candida growth assessed from chair-side tests.
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Measured: Baseline and 12 weeks.
Amount of oral Candida growth assessed from chair-side tests.
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Measured: Baseline and 12 weeks.
Secondary outcomes (2)
Change in levels of dental plaque
Secondary Outcome Measures will be measured before and after the intervention period.
Measured: Baseline and 12 weeks.
Changes in levels of gingival bleeding.
Secondary Outcome Measures will be measured before and after the intervention period.
Measured: Baseline and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2015 (estimated)
- Study startSep 2013
- Primary completionMar 2014
- Study completionJun 2015
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 CandidiasisStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Rose Jørgensen, University of Copenhagen
- Investigators
- Svante Twetman, Professor, Study director, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02391532
- Sponsor's protocol ID
- 2010/618
- Status last verified
- Aug 2015
- First submitted
- 6 Mar 2015
- Last updated
- 11 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kraft-Bodi E, Jorgensen MR, Keller MK, Kragelund C, Twetman S. Effect of Probiotic Bacteria on Oral Candida in Frail Elderly. J Dent Res. 2015 Sep;94(9 Suppl):181S-6S. doi: 10.1177/0022034515595950. Epub 2015 Jul 22.
PubMed 26202995
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Probiotic Bacteria (L. Reuteri) on Oral Candida Counts in Frail Elderly
- ClinicalTrials.gov ID
- NCT02391532
- Acronym / sponsor ID
- 2010/618
- Conditions
- Candidiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 18 Mar 2015 (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.
The aim of this study is to investigate the effect of daily intake of the probiotic Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in nursery homes.
Detailed description
The aim of the present study was to investigate the effect of a twice daily intake of lozenges containing probiotic Lactobacillus reuteri on the prevalence and counts of oral Candida in senior residents living in nursery homes. The material consists of 215 elderly persons (range 60 to 102 years) living in 20 different nursery homes in the County of Kronoberg, situated in the southern parts of Sweden. The subjects were consecutively enrolled after informed consent consisting of verbal and written information directed to the individual as well as to their relatives. The study employed a double-blind randomized placebo-controlled design.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri DSM 17938/ATCC PTA | Active comparator | Dietary Supplement: L. reuteri DSM 17938/ATCC PTAL. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo lozenges twice daily for 12 weeks |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- non-smoking
- ability to cooperate with a dental examination and saliva sampling
Key exclusion criteria (2 listed)
- severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs
- severe dementia or cognitive impairment
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 |
|---|---|---|
| L. reuteri DSM 17938/ATCC PTAIngestion of active lozenge twice daily for 12 weeks | Dietary supplement | L. reuteri DSM 17938/ATCC PTA |
| PlaceboIngestion of placebo lozenge twice daily for 12 weeks | Dietary supplement | Placebo |
Primary outcome
Prevalence of oral Candida growth assessed from chair-side tests.
Time frame: Baseline and 12 weeks.
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
Amount of oral Candida growth assessed from chair-side tests.
Time frame: Baseline and 12 weeks.
Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.
2 secondary outcomes
Change in levels of dental plaque
Time frame: Baseline and 12 weeks.
Changes in levels of gingival bleeding.
Time frame: Baseline and 12 weeks.
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 11 Aug 2015.
- Derived from this study: PubMed 26202995Kraft-Bodi E, Jorgensen MR, Keller MK, Kragelund C, Twetman S. Effect of Probiotic Bacteria on Oral Candida in Frail Elderly. J Dent Res. 2015 Sep;94(9 Suppl):181S-6S. doi: 10.1177/0022034515595950. Epub 2015 Jul 22.
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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.
Svante Twetman, Professor study director
University of Copenhagen
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri DSM 17938/ATCC PTA in people with Candidiasis, run by University of Copenhagen.
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: finished, as of the sponsor's last update on 11 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
Prevalence of oral Candida growth assessed from chair-side tests. (time frame: Baseline and 12 weeks.). The study lists 2 primary outcomes in all. 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 NCT02391532, 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 11 Aug 2015.