Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri

Periodontitis Clinical Trial

Official title:

Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02017886
• Other study ID #: H-4-2013-158
• Status: Completed
• Phase: N/A
• First received: December 4, 2013
• Last updated: May 10, 2016
• Start date: November 2013
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: April 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries
• Periodontitis

Intervention

Dietary Supplement:
• L. reuteri DSM 17938/ATCC PTA
L. reuteri DSM 17938/ATCC PTA twice daily for three weeks
• Placebo
Placebo tablet twice daily for three weeks

Locations

Country	Name	City	State
Denmark	University of Copenhagen	Copenhagen	Kbh. N

Sponsors (1)

Lead Sponsor	Collaborator
University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	No