NCT02391532

Brief Summary

The aim of this study is to investigate the effect of daily intake of the probiotic Lactobacillus Reuteri on the prevalence and counts of oral Candida in frail elderly living in nursery homes.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
215

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

March 6, 2015

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 18, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

August 11, 2015

Status Verified

August 1, 2015

Enrollment Period

6 months

First QC Date

March 6, 2015

Last Update Submit

August 10, 2015

Conditions

Candidiasis

Outcome Measures

Primary Outcomes (2)

  • Prevalence of oral Candida growth assessed from chair-side tests.

    Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.

    Baseline and 12 weeks.

  • Amount of oral Candida growth assessed from chair-side tests.

    Saliva and plaque samples will be analyzed and data presented when all 215 participants have completed the intervention period.

    Baseline and 12 weeks.

Secondary Outcomes (2)

  • Change in levels of dental plaque

    Baseline and 12 weeks.

  • Changes in levels of gingival bleeding.

    Baseline and 12 weeks.

Study Arms (2)

L. reuteri DSM 17938/ATCC PTA

ACTIVE COMPARATOR

L. reuteri DSM 17938/ATCC PTA lozenges twice daily for 12 weeks

Dietary Supplement: L. reuteri DSM 17938/ATCC PTA

Placebo

PLACEBO COMPARATOR

Placebo lozenges twice daily for 12 weeks

Dietary Supplement: Placebo

Interventions

L. reuteri DSM 17938/ATCC PTADIETARY_SUPPLEMENT

Ingestion of active lozenge twice daily for 12 weeks

L. reuteri DSM 17938/ATCC PTA
PlaceboDIETARY_SUPPLEMENT

Ingestion of placebo lozenge twice daily for 12 weeks

Placebo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • non-smoking
  • ability to cooperate with a dental examination and saliva sampling

You may not qualify if:

  • severe chronic disease, malignancies or ongoing medication with immunosuppressive drugs
  • severe dementia or cognitive impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Kraft-Bodi E, Jorgensen MR, Keller MK, Kragelund C, Twetman S. Effect of Probiotic Bacteria on Oral Candida in Frail Elderly. J Dent Res. 2015 Sep;94(9 Suppl):181S-6S. doi: 10.1177/0022034515595950. Epub 2015 Jul 22.

    PMID: 26202995DERIVED

MeSH Terms

Conditions

Candidiasis

Condition Hierarchy (Ancestors)

MycosesBacterial Infections and MycosesInfections

Study Officials

  • Svante Twetman, Professor

    University of Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

March 6, 2015

First Posted

March 18, 2015

Study Start

September 1, 2013

Primary Completion

March 1, 2014

Study Completion

June 1, 2015

Last Updated

August 11, 2015

Record last verified: 2015-08