Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
1 other identifier
interventional
47
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2013
CompletedFirst Submitted
Initial submission to the registry
December 4, 2013
CompletedFirst Posted
Study publicly available on registry
December 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedMay 11, 2016
May 1, 2016
2.1 years
December 4, 2013
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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.
Study Arms (2)
L. reuteri DSM 17938/ATCC PTA
ACTIVE COMPARATORL. reuteri DSM 17938/ATCC PTA twice daily for three weeks.
Placebo
PLACEBO COMPARATORPlacebo tablet twice daily for three weeks
Interventions
L. reuteri DSM 17938/ATCC PTA twice daily for three weeks
Eligibility Criteria
You may qualify if:
- Healthy individuals with no chronic compromising illnesses
- No medication intake for serious chronic diseases
You may not qualify if:
- Recent antibiotic therapy (within the last six months)
- Pregnant or lactating women
- Active infection that needs treatment with antibiotics
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Copenhagen
Copenhagen, Kbh. N, 2200, Denmark
Related Publications (1)
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.
PMID: 27104984DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mette Rose Jørgensen, PhD-student
University of Copenhagen
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD-student, dentist
Study Record Dates
First Submitted
December 4, 2013
First Posted
December 23, 2013
Study Start
November 1, 2013
Primary Completion
December 1, 2015
Study Completion
April 1, 2016
Last Updated
May 11, 2016
Record last verified: 2016-05