Food Derived Bacteria and Their Role in Treating Disease
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Characterisation of gut microbiome
研究概览
简要总结
The goal of this clinical trial is to examine the impact of food derived bacteria on gut microbiome composition and host health. The main questions it aims to answer are:
- what is the the rate of gastrointestinal colonisation of food derived bacteria?
- what is the contribution of food derived bacteria to gut microbiome stability?
Participants will complete a cross over feeding study of dietitian designed meals of known microbial load and will be asked to provide stool and blood samples for analysis.
详细描述
To understand the role and stability of food derived bacteria in impacting microbiome composition, 20 healthy participants will be recruited for this single site double blinded randomised controlled crossover pilot trial. The study is divided into four 14 day diet phases - baseline habitual, specified diet 1, habitual washout and specified diet 2. Participants will be randomly assigned to receive a microbial or non-microbial diet in specified diet 1 phase. Each participant will then crossover to receive the alternative diet in the specified diet 2 phase. The microbial and non-microbial diets will be identical except for the removal of naturally occurring food derived bacteria in non-microbial diet. At the commencement of the study and at the end of each diet phase, participants will attend a research clinic to undergo comprehensive clinical and anthropometric assessment and dietary evaluation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Have no genetic conditions (e.g. Prader Willi or Down's Syndrome)
- •Not diagnosed with a significant medical conditions (e.g. irritable bowel syndrome, inflammatory bowel disease or type 1/2 diabetes)
- •Do not require drug-therapy (e.g. steroids or insulin or antibiotics)
- •Not taking dietary supplements, probiotics, prebiotics, symbiotics or fibre supplementation
- •Any condition that will affect participation in the study
- •Not pregnant, planning a pregnancy or breastfeeding
- •Able to complete a two-month dietary study and agree to eating all meals provided
- •Have no dietary allergies or dietary restrictions that prevent consumption of provided study meals
- •Open bowels regularly - mostly daily
- •Able to read, write and understand English
排除标准
- •Dietary concerns identified by dietitian
- •Aged less than 18 years and older than 65 years
- •Diagnosed with a medical condition that requires drug therapy
- •Taking medications or supplements known to alter gastrointestinal microbiota
- •Women who are pregnant, planning a pregnancy or breastfeeding
- •Anyone with a diagnosed gastrointestinal condition/disease e.g. irritable bowel syndrome or inflammatory bowel disease
- •Known dietary allergy and/or intolerance, follows a vegan or vegetarian diet, or has coeliac disease
- •Anyone with a preference for specific food avoidance or exclusion of certain ingredients in habitual diet
- •Unable to tolerate blood collection procedures
- •Unable to provide regular stool samples throughout the study
结局指标
主要结局
Characterisation of gut microbiome
时间窗: Day 1, 4, 7, 11 and 14 of each phase
Sequencing and bacterial culturing of stool samples
次要结局
- Participant weight(Weight will be measured on day 14 (at end of each diet phase (fortnightly)))
- Resting systolic and diastolic blood pressure(Blood pressure will be measured on day 14 (at end of each diet phase (fortnightly)))
- Habitual dietary intake(Daily throughout 14-day baseline habitual and habitual washout phases)
- Participant body mass index (BMI)(BMI will be calculated on day 14 (at end of each diet phase (fortnightly)))
- Participant Hip circumference(Baseline day 1 and end of each 14-day diet phase)
- Mental Health Assessment(Completed at day 1 and end of study (day 56))
- Participant standing height(Height will be measured on day 14 (at end of each diet phase (fortnightly)))
- Dietary compliance(Day 1 to Day 14 of specified diet 1 and diet 2 phases)
- Lipid studies(Blood collected at baseline day 1 and day 14 of each phase (fortnightly))
- Participant waist circumference(Baseline day 1 and end of each 14-day diet phase)
- End of study optional semi-structured interview(End of study (at least 8 weeks post-randomisation))
- Gastrointestinal symptomatology(Baseline day 1 and day 14 of each diet phase (fortnightly))
- Bowel movement(Baseline day 1 and day 14 of each diet phase (fortnightly))
- Changes in physical activity levels(Completed at each of each 14-day diet phase)
- Glucose levels(Blood collected at baseline day 1 and day 14 of each phase (fortnightly))
- Irritable Bowel Syndrome-Severity Scoring System (IBS-SS)(End of each 14-day diet phase)
研究者
Dr. Sam Forster
Principal Investigator
Monash University