Salivary IgA and Cytokines Response to Dietary Supplementation of Lactobacillus Reuteri
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •Recent antibiotic therapy (within the last six months)
- •Pregnant or lactating women
- •Active infection that needs treatment with antibiotics
结局指标
主要结局
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.
时间窗: 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.
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.
次要结局
未报告次要终点
研究者
Mette Rose Jørgensen
PhD-student, dentist
University of Copenhagen