Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri

University of Copenhagen

Status: Completed

Conditions: Periodontitis; Dental Caries

Treatments: Dietary Supplement: Placebo; Dietary Supplement: L. reuteri DSM 17938/ATCC PTA

Study type: Interventional

Funder types: Other

Identifiers

NCT02017886

H-4-2013-158

Details and patient eligibility

About

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.

Full 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.

Enrollment: 47 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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47 participants in 2 patient groups, including a placebo group

L. reuteri DSM 17938/ATCC PTA

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: L. reuteri DSM 17938/ATCC PTA

Placebo

Placebo Comparator group

Description:

Placebo tablet twice daily for three weeks

Treatment:

Dietary Supplement: Placebo