Safety of Lactobacillus Reuteri (L. Reuteri) in Healthy Adults
Fjalë kyçe
Abstrakt
Përshkrim
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.
Datat
| Verifikuar së fundmi: | 12/31/2017 |
| Paraqitur së pari: | 06/14/2009 |
| Regjistrimi i vlerësuar u dorëzua: | 06/15/2009 |
| Postuar së pari: | 06/16/2009 |
| Përditësimi i fundit i paraqitur: | 01/22/2018 |
| Përditësimi i fundit i postuar: | 01/24/2018 |
| Data e fillimit të studimit aktual: | 09/30/2009 |
| Data e vlerësuar e përfundimit primar: | 06/30/2011 |
| Data e vlerësimit të përfundimit të studimit: | 06/30/2011 |
Gjendja ose sëmundja
Ndërhyrja / trajtimi
Biological: L. reuteri
Biological: Sunflower Oil
Faza
Grupet e krahëve
| Krah | Ndërhyrja / trajtimi |
|---|---|
| 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. |
Kriteret e pranimit
| Moshat e pranueshme për studim | 18 Years Për të 18 Years |
| Gjinitë e pranueshme për studim | All |
| Pranon Vullnetarë të Shëndetshëm | po |
| Kriteret | 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 |
Rezultati
Masat Kryesore të Rezultateve
1. Treatment of adults with probiotic (health-promoting bacteria) LR, will be safe and well-tolerated. [8/1/2009 - 7/1/2009]
Masat dytësore të rezultateve
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]
