NCT02017886

Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: University of Copenhagen · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

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.

Conditions

• Dental Caries
• Periodontitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	L. reuteri DSM 17938/ATCC PTA	L. reuteri DSM 17938/ATCC PTA twice daily for three weeks
DIETARY_SUPPLEMENT	Placebo	Placebo tablet twice daily for three weeks

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-12-01
• Completion: 2016-04-01
• First posted: 2013-12-23
• Last updated: 2016-05-11

Locations

1 site across 1 country: Denmark