Effects on Tablets Containing Probiotic Candidate Strains
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|ClinicalTrials.gov Identifier: NCT02633345|
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : June 15, 2016
The aim of the study is to investigate the effect of tablets containing probiotic candidate strains, on gingival inflammation and the levels of selected pro- and anti-inflammatory cytokines in gingival crevicular fluid (GCF). A secondary aim is to describe the effect of the tablets on the salivary microbiome. The null hypothesis is that the clinical measurements, levels of cytokines and microbial composition of saliva will not differ from baseline or between the study and control group.
The study is planned as a double-blind; placebo controlled randomized trial with two parallel arms. The intervention period is planned to be 4 weeks.
80 participants are planned to be enrolled after informed consent and then randomly allocated to either the probiotic group or the placebo group.
The participants are randomly assigned to one of the study groups and given supply of either probiotic tablets or placebo tablets.
The probiotic tablets contain Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2 at a dose of 1 * 109 CFU(Colony Forming Units)/tablet. The participants will take two tablets a day for four weeks. Follow up registrations are conducted after two weeks, four weeks and six weeks.
At each visit, saliva and GCF will be collected and then plaque index (PI)) and bleeding on probing (BOP) will be registered.
All data will be processed with SPSS software (v 22.0; Chicago, Ill, USA). The follow-up values are compared to baseline within each group by Wilcoxon paired two-sided test and differences between groups are analyzed by Wilcoxon unpaired test. A p-value < 0.05 is considered statistical significant.
The participants are fully covered by the patient insurance of The School of Dentistry which cover any damage to the trial participant during the study .There is no expected side effects to the treatment with probiotics. Probiotics are generally considered safe (GRAS: Generally Recognized As Safe) by The European Food Safety Authority (EFSA).
The participants will not benefit directly from the treatment, but the knowledge gained from the study might contribute to the prevention of microbial derived illnesses in the mouth, e.g. caries and periodontitis, in the future. The sample collection does not cause any discomfort to the participants and the tablets have no known side effects. Therefore, the personal benefit of the participants corresponds to the minimal risk and discomfort to the participants.
|Condition or disease||Intervention/treatment||Phase|
|Gingivitis||Dietary Supplement: Probiotic tablets Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Primary Purpose:||Basic Science|
|Official Title:||Effects on Tablets Containing Probiotic Candidate Strains on Clinical and Cytokine Markers of Gingival Inflammation and Composition of the Salivary Microbiome|
|Study Start Date :||September 2015|
|Actual Primary Completion Date :||April 2016|
|Actual Study Completion Date :||June 2016|
The probiotic tablets contain Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2 at a dose of 1 * 109 CFU/tablet. The participants will take two tablets a day for four weeks.
Dietary Supplement: Probiotic tablets
Tablets with both Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2. Two tablets a day for four weeks
Placebo Comparator: Control
Placebo tablets. The participants will take two tablets a day for four weeks.
Dietary Supplement: Placebo
- Cytokines in GCF: INFγ, TNF-α, IL-8, IL-10 and IL-12 (ng/uL) [ Time Frame: Baseline, two weeks, four weeks, 6 weeks ]Change between timepoints
- Plaque Index [ Time Frame: Baseline, two weeks, four weeks, 6 weeks ]Change between timepoints. Amount of plaque according to Loe Index
- Number of sites with Bleeding on Probing [ Time Frame: Baseline, two weeks, four weeks, 6 weeks ]Change between timepoints
- Salivary microbiome (ng/UL) [ Time Frame: Baseline, two weeks, four weeks, 6 weeks ]Concentration of 200 selected bacteria in saliva. Change between timepoints
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02633345
|University of Copenhagen|
|Copenhagen, Denmark, 2100|