Randomised, Double-blind, Placebo Controlled Cross-over Study to Determine the Beneficial Effects of Synbiotics and PromitorTM (Soluble Corn Flour)on Metabolism and Immunity in Healthy 60-80 Years Old Individuals
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The modulation of the gut microbiota by synbiotics and PromitorTM inflammatory/immune biomarkers
研究概览
简要总结
The aging process leads to a marked decline in immune function (immunosenescence), causing a significant reduction in immune response after vaccination or infections. Dietary intervention is an attractive, safe and non-invasive way to impact on gut bacteria and subsequently the functioning of the immune system. The ability of the dietary supplementation to alter these functions can be of particular importance in those groups that have an underdeveloped, poorly functioning immune system such as infants, immuno-compromised subjects or elderly. Research over the past two decades has provided evidence that administration of probiotics (live microorganisms which, when administered in adequate amounts, confer a health benefit on the host) could enhance immune function. Lactobacilli and bifidobacteria are the most common probiotics used in humans and various strains have been shown to have immunostimulatory properties in vitro and in experimental models, these properties include modulation of cytokine production. evidence exists of the immunostimulating effects of certain probiotics and the potential to use prebiotics to increase the levels of beneficial bacteria (which are known to be reduced in elderly population). Furthermore, by providing a probiotic at the same time as a prebiotic conditions for survival are enhanced. To date, only a small number of studies conducted have been randomised and/or placebo controlled to unequivocally demonstrate efficacies.
详细描述
The aim of this study is to investigate the effect of probiotic Lactobacillus rhamnosus GG (commercialised as LGG), a pilus-less derivative L. rhamnosus GG (LGG-PB12)combined with a putative prebiotic PromitorTM (soluble corn fiber) i.e. a synbiotics and PromitorTM (SCF alone) on the faecal microbiota composition, metabolism and immunity in healthy individuals aged 60-80 years.
It consists of a 3 week randomised intervention treatment periods with the synbiotics, prebiotic and placebo control. Any adverse medical events which occur during the trial (e.g. headache, gut symptoms) should be recorded in a diary along with medication taken.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Double Blind (Participant, Investigator,Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged between 60 and 80 years of age.
- •in good general health, defined as no comorbidities requiring regular medical follow up
- •Ability to communicate well with the investigator and to comply with the requirements of the entire study
排除标准
- •History or evidence of organic disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years
- •Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks and during the trial period
- •Former participation in another study involving prebiotic or probiotic preparations or investigational drugs within the previous 6 months, or intention to use such drugs during the course of the study
- •Undergone surgical resection of any part of the bowel
- •History of malignancy within the previous 5 years (with exception of well-treated basal cell carcinoma or in situ cervical carcinoma).
- •Currently prescribed immunosuppressive drugs
- •Intention to use regularly other medication which affects gastrointestinal motility and/or perception
- •Current or recent history (within 12 months) of significant drug or alcohol abuse or dependence
结局指标
主要结局
The modulation of the gut microbiota by synbiotics and PromitorTM inflammatory/immune biomarkers
时间窗: Changes from baseline to 21 days synbiotics and PromitorTM treatment
Fecal16S rRNA amplicon sequencing to assess changes in fecal bacterial abundance and species diversity
次要结局
- The modulation of immune function by synbiotics and PromitorTM(Changes from baseline to 21 days synbiotics and PromitorTM treatment)
研究者
DR ADELE COSTABILE
Health Sciences Research Centre, Life Science Department
University of Roehampton
