Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri

May 10, 2016 updated by: Mette Rose Jørgensen, University of Copenhagen
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

47

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Kbh. N
      • Copenhagen, Kbh. N, Denmark, 2200
        • University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: L. reuteri DSM 17938/ATCC PTA
L. reuteri DSM 17938/ATCC PTA twice daily for three weeks.
Dietary supplement: L. reuteri DSM 17938/ATCC PTA
L. reuteri DSM 17938/ATCC PTA twice daily for three weeks
Placebo Comparator: Placebo
Placebo tablet twice daily for three weeks
Dietary supplement: Placebo
Placebo tablet twice daily for three weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Investigators

  • Principal Investigator: Mette Rose Jørgensen, PhD-student, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

December 1, 2015

Study Completion (Actual)

April 1, 2016

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 16, 2013

First Posted (Estimate)

December 23, 2013

Study Record Updates

Last Update Posted (Estimate)

May 11, 2016

Last Update Submitted That Met QC Criteria

May 10, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-4-2013-158

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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