Periodontitis Clinical Trial
Official title:
Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
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 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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
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