Effects on Tablets Containing Probiotic Candidate Strains

NCT02633345 | Completed

• 1 other identifier: H-8-2014-014
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis

Outcome Measures

Primary Outcomes (3)

• Cytokines in GCF: INFγ, TNF-α, IL-8, IL-10 and IL-12 (ng/uL)

  Change between timepoints

  Baseline, two weeks, four weeks, 6 weeks

• Plaque Index

  Change between timepoints. Amount of plaque according to Loe Index

  Baseline, two weeks, four weeks, 6 weeks

• Number of sites with Bleeding on Probing

  Change between timepoints

  Baseline, two weeks, four weeks, 6 weeks

Secondary Outcomes (1)

• Salivary microbiome (ng/UL)

  Baseline, two weeks, four weeks, 6 weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

Placebo tablets. The participants will take two tablets a day for four weeks.

Dietary Supplement: Placebo

Interventions

Probiotic tablets DIETARY_SUPPLEMENT

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

Probiotic

Placebo DIETARY_SUPPLEMENT

Placebo tablets

Control

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

University of Copenhagen

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 10, 2015
• First Posted: December 17, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 15, 2016

Record last verified: 2016-06

Locations

DK (1)