NCT03210779

Brief Summary

This research will study the healing of standardized wounds created in the oral mucosa of volunteer participants during daily intake of tablets and topical application of oil containing the probiotic bacterium Lactobacillus reuteri. Our null hypothesis is that the consumption and topical application of probiotic supplements containing L. reuteri does not improve clinical healing of oral wounds in healthy participants when compared to controls.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2016

Shorter than P25 for not_applicable

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

December 5, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 7, 2017

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

July 3, 2017

Last Update Submit

May 18, 2018

Conditions

Wound

Keywords

oral wound healingprobiotics

Outcome Measures

Primary Outcomes (1)

  • Percentage (%) of initial wound size area, measured in digital photographs

    The reference value (100%) will be the area before intervention. The percentage is calculated with the second measure (photograph after the intervention)

    8 days

Secondary Outcomes (3)

  • Levels of salivary oxytocin and salivary IL-10, in pg/ml

    8 days

  • Levels of TNF-α and Interleukin 1β in the wound exudate

    8 days

  • Numerical estimation of S. aureus and β-haemolitic streptococci (CFU/ml)

    8 days

Study Arms (2)

L.reuteri

ACTIVE COMPARATOR

L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA lozenges three times daily for 16 days + L. reuteri DSM 17938/ATCC PTA L. reuteri DSM 17938/ATCC PTA probiotic oil, topically, once daily for 8 days.

Dietary Supplement: L. reuteri DSM 17938/ATCC PTA

Placebo

PLACEBO COMPARATOR

Placebo lozenges three times daily for 16 days and placebo oil once daily for 8 days

Dietary Supplement: Placebo

Interventions

L. reuteri DSM 17938/ATCC PTADIETARY_SUPPLEMENT

Ingestion of active lozenge twice daily for 16 days and topical application of active oil once daily for 8 days

L.reuteri
PlaceboDIETARY_SUPPLEMENT

Ingestion of inactive lozenge twice daily for 16 days application of inactive oil once daily for 8 days

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy individuals (no chronic compromising illnesses)
  • Healthy oral conditions
  • Good level of oral hygiene

You may not qualify if:

  • Adults over 50 years old
  • Previous allergic reaction to local anesthetics
  • Compromised oral mucosa
  • Systemic diseases
  • Obesity
  • Alcoholism
  • Smoking habit
  • Pregnancy
  • Antibiotic therapy within the last two months
  • Active infection that needs treatment with antibiotics
  • Systemic medications (glucocorticoid steroids, non-steroidal anti-inflammatory drugs -NSAIDS, chemotherapy, anticoagulant therapy) Contraceptives allowed.
  • Thrombocytopenia or any of various inherited coagulopathies.
  • Patients undergoing radiotherapy
  • Inability to provide informed consent by means of physical or mental handicap

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Erdman SE, Poutahidis T. Probiotic 'glow of health': it's more than skin deep. Benef Microbes. 2014 Jun 1;5(2):109-19. doi: 10.3920/BM2013.0042.

    PMID: 24675231BACKGROUND

  • Twetman S, Pedersen AML, Yucel-Lindberg T. Probiotic supplements containing Lactobacillus reuteri does not affect the levels of matrix metalloproteinases and interferons in oral wound healing. BMC Res Notes. 2018 Oct 25;11(1):759. doi: 10.1186/s13104-018-3873-9.

    PMID: 30359300DERIVED

MeSH Terms

Conditions

Wounds and Injuries

Study Officials

  • Svante Twetman, PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double Blind (Participant, Care Provider, Investigator)
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Model Details: Cross-over pilot trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 7, 2017

Study Start

December 5, 2016

Primary Completion

June 30, 2017

Study Completion

June 30, 2017

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share