Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
关键词
抽象
描述
Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract micro flora and prevention and treatment of mild diarrhea associated with GI-tract infections. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. The patients will receive 5 drops (10^8 live organisms) by mouth daily for 60 days. Daily administration will include 5 drops (5x10^8) of L. reuteri or placebo daily for two months. During this time,circulating peripheral blood mononuclear cell (PBMC) toll-like receptor-2 and -4 levels will be measured, along with PBMC cytokine production levels in vitro. Fecal DGGE analysis(with sequencing of bacterial rDNA) will be completed identifying changes in fecal microbiota. Inflammation in the gut will also be assessed by fecal calprotectin assay (ELISA). The time on study treatment is 2 months, with 4 months observation, for a total of 6 months. There will be 7 required visits, during which, we will assess safety and immune system effects.
日期
| 最后验证: | 12/31/2017 |
| 首次提交: | 06/14/2009 |
| 提交的预估入学人数: | 06/15/2009 |
| 首次发布: | 06/16/2009 |
| 上次提交的更新: | 01/22/2018 |
| 最近更新发布: | 01/24/2018 |
| 实际学习开始日期: | 09/30/2009 |
| 预计主要完成日期: | 06/30/2011 |
| 预计完成日期: | 06/30/2011 |
状况或疾病
干预/治疗
Biological: L. reuteri
Biological: Sunflower Oil
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Active Comparator: L. reuteri Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment and maintenance of a well-functioning gastro-intestinal (GI) tract microflora and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment. The oil drops contain a dietary supplement of Lactobacillus reuteri DSM 17938. | Biological: L. reuteri The oil drops contains 10^8 CFU (colony forming units). As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. The dose given is within the release limit which is greater than 2 x 10^8 CFU/ 5 drops and less than 8 x 10^8 CFU/ 5 drops. |
| Placebo Comparator: Sunflower Oil Placebo will be the equivalent number of drops of suspended sunflower oil (without LR), provided by Biogaia. | Biological: Sunflower Oil As suggested by the manufacturer in the Certificate of Analysis the daily dose given to each patient will be 5 x 10^8 CFU/ 5 drops. |
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Healthy Adults (18 - 60 years old) - No other recognized illness Exclusion Criteria: - Pregnancy or breastfeeding - Patient taking immunosuppressive medications, including oral corticosteroids - Positive result of HIV, Hepatitis B, and/or Hepatitis C test - Abnormal lab test results - Gastrointestinal related diseases and surgeries - Patients with an allergy to antibiotics - Presence of fever or a pre-existing adverse event monitored in the study - No more than two study participants in one household - Use of probiotics in the last 90 days - Diarrheal illness within the past 30 days - Recent or current use of oral antibiotics /anti-fungals(in the past 2 weeks) - Current use of oral laxatives - Chronic alcohol use or more than 1 drink per day - Subjects with implanted prosthetic devices including prosthetic heart valves - Known sensitivity to sunflower oil or products containing linolenic/oleic acids - Will require that subject not take any other probiotic-containing products, including yogurt supplemented with probiotics during the 6-month period |
结果
主要结果指标
1. Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated. [8/1/2009 - 7/1/2009]
次要成果指标
1. Determine if LR treatment affects circulating levels of pro-inflammatory and anti-inflammatory cytokines, along with expression levels of toll like receptors (TLRs)-2 and -4 in circulating peripheral blood mononuclear cells. [4/1/2009-7/1/2009]
