Study of the Modularity Immune Function of Lactobacillus Rhamnosus GG in the Small Intestine of Healthy Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Microbiome of duodenal mucosal biopsies
研究概览
简要总结
The aim of this study was to investigate the host-microbe interaction effects of various Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in the small intestine, in healthy individuals
详细描述
The project consisted in the supplementation of a) a wild-type LGG strain, b) a low-producing pili LGG strain or c) a high-producing pili LGG strain to study subjects. The individuals received the three treatment combinations in a randomised order. Each supplementation was given to the individuals every 30 min over a period of 6 hours. Eight biopsies from the duodenum were collected at the end of 6 h-solutions administration by flexible gastroduodenoscopy, likewise the routine procedure during this endoscopic investigation. Faecal samples were collected by the study subjects at home 1 day before, 2, 7 and 14 days days after administrations of each oral supplementation. The supplementations were separated by a 3-week wash-out period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
The sachets containing the different LGG strains were labelled as A, B, and C. The codes for each strain were kept by the industrial partner that provided the probiotic strains. Only at the end of the data analyses were the codes disclosed
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy males or females aged 18-65 years.
- •Willing to abstain from any probiotics or medication known to alter gastrointestinal function during the study.
- •A signed informed consent.
排除标准
- •Recent or current treatment with drugs affecting intestinal function, immune function or mood (e.g. antidepressants). In addition use of all drugs during the study should be recorded.
- •Recent (< 6 weeks) use of probiotics*.
- •Diagnosis of major psychiatric or somatic disorders.
- •Pregnancy or breastfeeding.
- •Abuse of alcohol or drugs.
- •Smokers and chewable tobacco users.
- •Lactose intolerance.
- •Any kind of probiotics and with special attention on products containing LGG:
- •Dairy products:
- •Valio Kefir
- •Valio Gefilus yoghurt
- •Dietary supplements:
- •Bifiform Daily
- •Bifiform Travel
- •Bifiform Daily Caps
结局指标
主要结局
Microbiome of duodenal mucosal biopsies
时间窗: 6hrs supplementation after start of LGG strain administration
Bacterial composition was analysed by Illumina MiSeq sequencing the hypervariable V3-V4 region of the 16S rRNA gene
Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain
时间窗: 6hrs supplementation after start of LGG strain administration.
Microarray-based Gene expression Analysis were carried out from duodenal biopsies collected after the supplementation of each LGG strain
次要结局
- Faecal microbiome(14 days after LGG strain administration)
研究者
Robert Brummer
Professor
Örebro University, Sweden