Probiotic Lactobacillus Reuteri and Oral Microbiota

NCT02311218 | Completed Phase 2

• 1 other identifier: Umea university
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

In February 2013, 44 healthy adults was recruited and randomized to daily intake of lozenges with or without Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks. The effect of these Lactobacillus reuteri strains on the oral microbial composition was monitored before, after 4, 8 and 12 weeks and after 1 and 6 months after exposure was completed. For this purpose saliva and tooth plaque was collected. Of 44 included subjects, 41 completed the study. The used Lactobacillus reuteri containing lozenges are commercially available and identical placebo lozenges was obtained from the manufacturer. The study product was well tolerated with no observed side effects. Compliance was excellent. The investigators' primary outcome was to determine whether daily intake of Lactobacillus reuteri strains DSM 17938 and PTA 5289 for 12 weeks alters the tooth colonizing bacterial plaque composition determined by a multiplex sequencing technique. Effects are put in relation to general knowledge on bacterial profiles associated with risk to develop dental caries and periodontitis.

Conditions

Dental Plaque

Keywords

oral, microbiota, lactobacillus reuteri,

Outcome Measures

Primary Outcomes (1)

• Change in oral bacteria biofilm composition after 12-week supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289

  The change in bacteria colonizing the oral cavity after 12 weeks treatment with L. reuteri is analyzed

  Baseline, after 4, 8 and 12 week treatment, and 1 and 6 months after treatment has terminated

Study Arms (2)

Test group with L. reuteri

ACTIVE COMPARATOR

Subjects in the test group take one Lactobacillus reuteri DSM 17938 and PTA 5289 containing lozenge in the morning and one in the evening.

Dietary Supplement: Lactobacillus reuteri DSM 17938 and PTA 5289

Placebo group without L. reuteri

PLACEBO COMPARATOR

Subjects in the placebo group take one placebo lozenges with same look, taste and smell as the test lozenge but lacking the Lactobacillii the morning and one in the evening.

Dietary Supplement: Placebo

Interventions

Lactobacillus reuteri DSM 17938 and PTA 5289 DIETARY_SUPPLEMENT

Subjects in the test group are given one lozenges with Lactobacillus reuteri DSM 17938 and PTA 5289 in the morning and one in the evening

Test group with L. reuteri

Placebo DIETARY_SUPPLEMENT

Placebo lozenges with no Lactobacillus reuteri DSM 17938 and PTA 5289

Placebo group without L. reuteri

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult,
• healthy,
• no antibiotic treatment and no intake of probiotic products latest 3 months

You may not qualify if:

• Acute or chronic disease at recruitment, medication.

Sponsors & Collaborators

• Umeå University: lead

Related Publications (1)

• Romani Vestman N, Chen T, Lif Holgerson P, Ohman C, Johansson I. Oral Microbiota Shift after 12-Week Supplementation with Lactobacillus reuteri DSM 17938 and PTA 5289; A Randomized Control Trial. PLoS One. 2015 May 6;10(5):e0125812. doi: 10.1371/journal.pone.0125812. eCollection 2015.

  PMID: 25946126 DERIVED

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ingegerd Johansson, Professor

  Umea university, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2014
• First Posted: December 8, 2014
• Study Start: March 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: December 8, 2014

Record last verified: 2014-11