THE EFFECTS OF HUMAN-MILK-OLIGOSACCHARIDES ON THE FAECAL MICROBIOTA AND ON GASTROINTESTINAL SYMPTOMS IN HEALTHY VOLUNTEERS A PARALLEL, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED DOSE FINDING STUDY
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Plasma concentration of study product
研究概览
简要总结
The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study with healthy volunteers. A total of 100 male and female volunteers will be included. The volunteers will be randomized into one of 10 groups, each of 10 participants, consuming either active product in various mixes and doses (9 groups) or placebo product (1 group) for 2 weeks. The 9 groups receiving active product will receive either one of two Human Milk Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of the study is establishing the effects of various compositions and doses of HMOs on the faecal flora and on gastrointestinal symptoms in health adults.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed written informed consent
- •Ability and willingness to understand and comply to the study procedures
排除标准
- •Participation in a clinical study one month prior to screening visit and throughout the study.
- •Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator.
- •Any gastrointestinal symptom scored >3 on the GSRS during the screening period
- •A mean score on the total GSRS >2 (i.e. above the population norm value) during the screening period
- •Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator.
- •Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator.
- •Severe psychiatric disease, as judged by the investigator.
- •Use of highly dosed probiotic supplements (yoghurt allowed) 3 months prior to the study and throughout the study.
- •Consumption of antibiotic drugs 3 months prior to screening and throughout the study.
- •Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study.
- •Pregnant or lactating or wish to become pregnant during the period of the study.
- •Lack of suitability for participation in the study for any reason as judged by the investigator.
结局指标
主要结局
Plasma concentration of study product
时间窗: 0, 3, 6, and 9 hours post intake of study product.
Detectability of study product in plasma at 0, 3, 6 and 9 hours post intake.
Concentration of study product in urine
时间窗: 0 and 6 hours post intake
Detectability of study product in urine 6 hours post intake
Change from baseline in faecal microbiota
时间窗: Baseline and after 2 weeks of intake
Change from baseline in microbiota after 2 weeks of intake
Change from baseline in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS)
时间窗: Baseline and after 2 weeks of intake
Change from baseline in GSRS after 2 weeks of intake
Change from baseline in Bristol Stool form (BSF) scale
时间窗: Baseline and during intake. Registered daily during study period.
Change from baseline in BSF during intake
次要结局
- Change in specific biomarkers in faeces(Baseline and after 2 weeks of intake)
- Change in specific biomarkers in serum(Baseline and after 2 weeks of intake)
- Number of participants with adverse events(Baseline to end of the 2 weeks of intake)
- Change in clinical chemistry(Baseline and after 2 weeks of intake)
- Change in haematology(At baseline and after 2 weeks of intake)