Clinical trial NCT02017886: Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
Official title: Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Caries
Periodontitis
Keywords: Probiotics
Oral health
Innate immunity
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2013-12-23
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: University of Copenhagen
state: Kbh. N
Study officials:
affiliation: University of Copenhagen
name: Mette Rose Jørgensen, PhD-student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jorgensen MR, Keller MK, Kragelund C, Hamberg K, Ericson D, Nielsen CH, Twetman S. Lactobacillus reuteri supplements do not affect salivary IgA or cytokine levels in healthy subjects: A randomized, double-blind, placebo-controlled, cross-over trial. Acta Odontol Scand. 2016 Jul;74(5):399-404. doi: 10.3109/00016357.2016.1169439. Epub 2016 Apr 22.