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Effects on Tablets Containing Probiotic Candidate Strains

NCT02633345 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-06-15

No results posted yet for this study

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.

Conditions

  • Gingivitis

Interventions

DIETARY_SUPPLEMENT

Probiotic tablets

Tablets with both Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2. Two tablets a day for four weeks

DIETARY_SUPPLEMENT

Placebo

Placebo tablets

Sponsors & Collaborators

  • University of Copenhagen

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-04-30
Completion
2016-06-30

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02633345 on ClinicalTrials.gov