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Effects on Tablets Containing Probiotic Candidate Strains

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02633345
Recruitment Status : Completed
First Posted : December 17, 2015
Last Update Posted : June 15, 2016
Sponsor:
Information provided by (Responsible Party):
Mette Kirstine Keller, University of Copenhagen

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: Probiotic
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
Placebo tablets




Primary Outcome Measures :
  1. 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

  2. Plaque Index [ Time Frame: Baseline, two weeks, four weeks, 6 weeks ]
    Change between timepoints. Amount of plaque according to Loe Index

  3. Number of sites with Bleeding on Probing [ Time Frame: Baseline, two weeks, four weeks, 6 weeks ]
    Change between timepoints


Secondary Outcome Measures :
  1. Salivary microbiome (ng/UL) [ Time Frame: Baseline, two weeks, four weeks, 6 weeks ]
    Concentration of 200 selected bacteria in saliva. Change between timepoints



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • presence of at least two buccal marginal sites with moderate gingival inflammation according to the Löe index with a probing depth of ≤ 5 mm

Exclusion Criteria:

  • regular intake of probiotic bacteria
  • smoking
  • pregnancy
  • intake of antibiotics within the last two months before baseline
  • low stimulated saliva rate (0,8 ml/min)
  • rampant decay with several untreated caries lesions

Information from the National Library of Medicine

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


Locations
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Denmark
University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
University of Copenhagen
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Responsible Party: Mette Kirstine Keller, Assistant Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT02633345    
Other Study ID Numbers: H-8-2014-014
First Posted: December 17, 2015    Key Record Dates
Last Update Posted: June 15, 2016
Last Verified: June 2016
Additional relevant MeSH terms:
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Gingivitis
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases