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Effect of Probiotics on Oral Wound Healing - Pilot Study (PROWOUND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03210779
Recruitment Status : Completed
First Posted : July 7, 2017
Last Update Posted : May 22, 2018
Sponsor:
Collaborator:
Karolinska Institutet
Information provided by (Responsible Party):
Svante Twetman, University of Copenhagen

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.

Condition or disease Intervention/treatment Phase
Wound Dietary Supplement: L. reuteri DSM 17938/ATCC PTA Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Cross-over pilot trial
Masking: Double (Participant, Care Provider)
Masking Description: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Official Title: Effect of Probiotic Tablets and Topical Probiotic Oil (Lactobacillus. Reuteri) on Oral Wound Healing (Pilot Study)
Actual Study Start Date : December 5, 2016
Actual Primary Completion Date : June 30, 2017
Actual Study Completion Date : June 30, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: L.reuteri
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
Ingestion of active lozenge twice daily for 16 days and topical application of active oil once daily for 8 days

Placebo Comparator: Placebo
Placebo lozenges three times daily for 16 days and placebo oil once daily for 8 days
Dietary Supplement: Placebo
Ingestion of inactive lozenge twice daily for 16 days application of inactive oil once daily for 8 days




Primary Outcome Measures :
  1. Percentage (%) of initial wound size area, measured in digital photographs [ Time Frame: 8 days ]
    The reference value (100%) will be the area before intervention. The percentage is calculated with the second measure (photograph after the intervention)


Secondary Outcome Measures :
  1. Levels of salivary oxytocin and salivary IL-10, in pg/ml [ Time Frame: 8 days ]
    As measured with standardized immuno-assays (ELISA kits)

  2. Levels of TNF-α and Interleukin 1β in the wound exudate [ Time Frame: 8 days ]
    As measured with standardized immuno-assays (ELISA kits)

  3. Numerical estimation of S. aureus and β-haemolitic streptococci (CFU/ml) [ Time Frame: 8 days ]
    As measured from bacterial cultures obtained from wound smears



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03210779


Sponsors and Collaborators
University of Copenhagen
Karolinska Institutet
Investigators
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Principal Investigator: Svante Twetman, PhD University of Copenhagen
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Svante Twetman, Professor, University of Copenhagen
ClinicalTrials.gov Identifier: NCT03210779    
Other Study ID Numbers: 2016-2430
First Posted: July 7, 2017    Key Record Dates
Last Update Posted: May 22, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Svante Twetman, University of Copenhagen:
oral wound healing
probiotics
Additional relevant MeSH terms:
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Wounds and Injuries