NCT01303484已完成早期 1 期
A Randomised, Double-blind, Placebo Controlled Cross- Over Study to Determine the Effect of prebioticB-GOS on the Immune Function, Metabolism and Gut Microbiota of Elderly People
Clasado1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年5月1日最近更新:
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers
研究概览
简要总结
The purpose of this study is to determine the effects of prebiotic B-GOS on the immune function, metabolism and gut microbiota of elderly people
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged between 65 and 80 years of age.
- •In good general health
- •The volunteer has given written informed consent to participate and is willing to participate in the entire study.
排除标准
- •History or evidence of disease of the gastrointestinal tract; such as tumour, irritable bowel syndrome, etc., within the previous 5 years.
- •Family history of colorectal cancer in under 50's
- •Consumed probiotic or prebiotic preparations on a regular basis (at least 3 times per week) in the last 2 weeks.
- •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 (please note sensory evaluations are still permitted).
- •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).
- •Lactose intolerant
- •Allergic to gluten
- •Currently prescribed immunosuppressive drugs. Participants will be required to withdraw should they begin taking any of the ineligible medication.
- •Intention to use regularly other medication which affects gastrointestinal motility and/or perception.
- •History of alcohol or drug misuse.
- •Suffer from any major conditions involving the following:
- •Head, Ears, Eyes, Nose and Throat Dermatological/Connective tissue Coeliac disease Neurological Lymphatic Urogenital/Rectal Gastroenterological Abdominal Respiratory Cardiovascular Incontinence
结局指标
主要结局
Effect of B-GOS on immunity by measuring various inflammatory/immune biomarkers
时间窗: 12 months
Effect of B-GOS on the faecal microbiota composition of elderly persons
时间窗: 12 months
Effect of aging on body metabolites using NMR
时间窗: 12 months
次要结局
- Effect of B-GOS on gut permeability(12 months)
- Weekly assessment of stools and gastrointestinal symptoms(8 months)
研究者
研究点 (1)
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