Colonization, Safety, Tolerance, and Effects of Three Probiotic Strains on the Immune System of Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 4
- 主要终点
- Gastrointestinal Tolerance After Probiotic Consumption.
研究概览
简要总结
The present report describes the design of a clinical trial performed on healthy adult individuals to check whether the daily intake of the new Hero strains contribute to intestinal colonization, under safe and tolerable conditions, with a positive contribution to health and wellbeing of healthy individuals.
Daily intake of one or several probiotic strains, (CNCM I-4034, CNCM I-4035, CNCM I-4036), increases intestinal microbiota in healthy adults, being safe and well tolerated. The regular intake has positive effects on the gastrointestinal and immune system.
详细描述
The project will be based on a double-blind, randomized, and placebo-controlled clinical trial. It will be multi-Centre, with four groups plus a control group.
The colonization performed by the strains and the modification of the intestinal microbiota will be evaluated by means of strain identification with RT-PCR equipped with specific primers, and bacterial population counting with in situ immunofluorescence techniques.
The safety of strain intake will be evaluated with physical examination, blood parameters, and test son faeces to check for resistance to ampicillin and tetracycline by lactic flora.
Tolerance will be evaluated by means of the record of gastrointestinal symptoms and the record of aspect and frequency of faeces.
The effect on the systemic and adaptive immune system will be measured by means of lymphocyte populations and plasma cytokine present on blood, IgAs on serum, saliva and faeces. Also AGCC on faeces.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult
- •Age: 18-50 years
- •Normal defecation
- •Normal blood parameters
- •Body Mass Index: 18-30
排除标准
- •Pregnancy
- •Lactation
- •Antibiotic treatment
- •Gastrointestinal disease
- •Diarrhoea
- •Constipation
- •Abnormal blood pressure
研究组 & 干预措施
Group A
Volunteers received Probiotic CNCM I-4034.
干预措施: Probiotic CNCM I-4034 (Other)
Group B
Volunteers receive Probiotic CNCM I-4035.
干预措施: Probiotic CNCM I-4035 (Other)
Group C
Volunteers are given Probiotic CNCM I-4036.
干预措施: Probiotic CNCM I-4036 (Other)
Group D
Volunteers receive Probiotics CNCM I-4035 and CNCM I-4036.
干预措施: Probiotics CNCM I-4035 and CNCM I-4036 (Other)
Group E
Volunteers receive a Placebo.
干预措施: Placebo (Other)
结局指标
主要结局
Gastrointestinal Tolerance After Probiotic Consumption.
时间窗: 4 weeks of the treatments. Daily recorded.
Tolerance of these probiotic strains was determined using the gastrointestinal symptom rating scale (GSRS), daily recorded gastrointestinal symptoms and defecation frequency.Intolerance was defined as a symptom score of 2 or higher on the GSRS. The unit of measure is the "number of participants" was tolerant to the intervention.
次要结局
- Gastrointestinal and Immune Effects of Probiotics Consumption.(At Time zero, after 4 weeks, and 2 later.)
研究者
Pedro Abellan
Project Manager
Hero Institute for Infant Nutrition