Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
Primary Purpose
Dental Caries, Periodontitis
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
L. reuteri DSM 17938/ATCC PTA
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries focused on measuring Probiotics, Oral health, Innate immunity
Eligibility Criteria
Inclusion Criteria:
- Healthy individuals with no chronic compromising illnesses
- No medication intake for serious chronic diseases
- No regular intake of probiotic products up till one month before inclusion
Exclusion Criteria:
- Recent antibiotic therapy (within the last six months)
- Pregnant or lactating women
- Active infection that needs treatment with antibiotics
Sites / Locations
- University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
L. reuteri DSM 17938/ATCC PTA
Placebo
Arm Description
L. reuteri DSM 17938/ATCC PTA twice daily for three weeks.
Placebo tablet twice daily for three weeks
Outcomes
Primary Outcome Measures
The overall aim of this study is to evaluate the effect of daily ingestion of Lactobacillus reuteri on the levels of secretory IgA and cytokines in whole saliva of healthy adults.
Endpoints: The concentration of total protein and secretory IgA in saliva are determined in duplicates with the Bio-Rad protein assay and enzyme-linked immune-sorbent assay (ELISA), respectively. Values are express as mg/100ml or %IgA/protein.
Secondary Outcome Measures
Full Information
NCT ID
NCT02017886
First Posted
December 4, 2013
Last Updated
May 10, 2016
Sponsor
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT02017886
Brief Title
Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
Official Title
Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
April 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effect of daily ingestion of the probiotic Lactobacillus reuteri on the levels of secretory IgA and the cytokines Il1-beta, IL-6, IL-8 and IL-10 in saliva of healthy young adults.
Detailed Description
Study design: A randomized, double-blind, cross-over design separated by three weeks run-in and wash-out periods. Each intervention period is three weeks and the participants are allocated to the test and placebo regimes in a randomized order.
Material: 41 healthy adults are enrolled after informed consent from the School of Dentistry, University of Copenhagen.
Methods: Samples of resting, unstimulated whole saliva (UWS) and stimulated whole saliva (SWS) are collected five times during the study period. The samples are immediately frozen in 0.5 ml aliquots.
Intervention: The subjects are instructed to ingest two tablets containing Lactobacillus reuteri or placebo, twice daily for 3 weeks. No probiotic food or health products are allowed during the intervention period. All normal oral hygiene routines should be maintained during the entire study. The compliance is checked through interviews. Any perceived side effects are reported without delay to the research staff.
Endpoints: The concentration of total protein and secretory IgA in saliva are determined with the enzyme-linked immune-sorbent assay (ELISA). The levels of the cytokines IL1-beta, IL-6, IL-8 and IL-10 is determined by Luminex-technology.
Scientific importance: The study may provide evidence that probiotic supplements can influence the innate defense system in the whole saliva which may open up for novel strategies to combat oral diseases.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries, Periodontitis
Keywords
Probiotics, Oral health, Innate immunity
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
47 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L. reuteri DSM 17938/ATCC PTA
Arm Type
Active Comparator
Arm Description
L. reuteri DSM 17938/ATCC PTA twice daily for three weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo tablet twice daily for three weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
L. reuteri DSM 17938/ATCC PTA
Intervention Description
L. reuteri DSM 17938/ATCC PTA twice daily for three weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo tablet twice daily for three weeks
Primary Outcome Measure Information:
Title
The overall aim of this study is to evaluate the effect of daily ingestion of Lactobacillus reuteri on the levels of secretory IgA and cytokines in whole saliva of healthy adults.
Description
Endpoints: The concentration of total protein and secretory IgA in saliva are determined in duplicates with the Bio-Rad protein assay and enzyme-linked immune-sorbent assay (ELISA), respectively. Values are express as mg/100ml or %IgA/protein.
Time Frame
Participants will be followed for 12 weeks after inclusion. Saliva samples will be analyzed and data presented when all 40 participants have completed the intervention period.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy individuals with no chronic compromising illnesses
No medication intake for serious chronic diseases
No regular intake of probiotic products up till one month before inclusion
Exclusion Criteria:
Recent antibiotic therapy (within the last six months)
Pregnant or lactating women
Active infection that needs treatment with antibiotics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mette Rose Jørgensen, PhD-student
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Copenhagen
City
Copenhagen
State/Province
Kbh. N
ZIP/Postal Code
2200
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
27104984
Citation
Jorgensen MR, Keller MK, Kragelund C, Hamberg K, Ericson D, Nielsen CH, Twetman S. Lactobacillus reuteri supplements do not affect salivary IgA or cytokine levels in healthy subjects: A randomized, double-blind, placebo-controlled, cross-over trial. Acta Odontol Scand. 2016 Jul;74(5):399-404. doi: 10.3109/00016357.2016.1169439. Epub 2016 Apr 22.
Results Reference
derived
Learn more about this trial
Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
We'll reach out to this number within 24 hrs