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临床试验/NCT00611299
NCT00611299已完成1 期

Dose-Response Study of Probiotic Bacteria Bifidobacterium Animalis Subsp. Lactis BB-12 and Lactobacillus Paracasei Subsp. Paracasei CRL-341 in Healthy Young Adults

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2003年4月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
71
试验地点
2
主要终点
Modulation of the immune system

研究概览

简要总结

The purpose of the study was to investigate the dose-response effect of increasing doses of Bifidobacterium animalis ssp lactis (BB-12) and Lactobacillus paracasei ssp paracasei (CRL-431) on the immune response, blood lipids, gut microflora, recovery from feces and overall tolerance in healthy young adults.

详细描述

The study included seventy-one healthy young vounteers, and was designed as a double-blind placebo controlled dose-response trial based on a 2 wk run-in period, a 3 wk intervention and 2 wk wash-out period. The subjects were randomly assigned into 5 groups of 15 subjects each, who were supplemented with 0, 10E8, 10E9, 10E10 or 10E10 CFU/d, respectively, og a mixture of BB-12 and CRL-431. Blood samples were collected 4 times and fecal samples 3 times. Diary reporting bowel habits and weel being was kept for all 7 weeks.

There are very few articles concerning the issue dose-response effect of probiotics.The aim of the study was to investigate the dose-response effect of increasing concentrations of probiotics on the immune response, blood lipids, composition of the gut microflora, recovery from feces and the overall tolerance.

The hypothesis was that the increasing dose would influence the immunresponse (eg incresae phagocytosis), improve blood lipid profile (eg.lower HDL-cholesterol), would be recovered in increasing concentrations in feces, would change the intestinal microfloraprofile and would be well tolerated even in high doses.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy young individuals

排除标准

  • GI-disease
  • Pregnant or lactating women
  • Individuals receiving the following medicine: antacid, antibiotics, steroids, medicine with influence the intestinal function.

结局指标

主要结局

Modulation of the immune system

Influence on blood lipids

Bioavailibility of BB-12 and CRL-341

Overall tolerance

Effect on the composition of the gut microflora

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (2)

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