Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2016-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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L. reuteri DSM 17938/ATCC PTA

L. reuteri DSM 17938/ATCC PTA twice daily for three weeks.

Group Type ACTIVE_COMPARATOR

L. reuteri DSM 17938/ATCC PTA

Intervention Type DIETARY_SUPPLEMENT

L. reuteri DSM 17938/ATCC PTA twice daily for three weeks

Placebo

Placebo tablet twice daily for three weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo tablet twice daily for three weeks

Interventions

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L. reuteri DSM 17938/ATCC PTA

L. reuteri DSM 17938/ATCC PTA twice daily for three weeks

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo tablet twice daily for three weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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