Evaluate the Colonization Capacity of a New Generation Probiotic Within the Project: Valorization of an Intestinal Bacterium as a Functional Ingredient to Prevent the Development of Metabolic Syndrome and Diabetes -BIOPRED
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Presence of our bacteria in feces
研究概览
简要总结
The goal of this interventional study is to test the colonization of a new generation probiotic in normal weight and overweight/obese people.
The main question aims to answer is if our bacteria is able to colonize the human intestine.
Participants will recieve a probiotic pill every day during 15 consecutive days and fill in questionaries.
详细描述
Normal weight and overweight volunteers will be recruited to evaluate the colonization capacity of the bacteria. In this case, stool samples will be taken before starting the intervention (T0), after the treatment (T1) and a week after fiinishing the administration of the probiotic (T2). All the subjects will receive the probiotic supplement in capsules taken daily, 7-8 normal weight subjects will take a concentration of 10^9-10 CFU and 7-8 overweight subjects will take a concentration of 10^9-10 CFU.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Samples will be coded and they will not know the pacient personal/sociodemographic data.
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
- •Age between 18 and 65 years.
- •Body mass index between 20-25 kg/m2 for normopese subjects and BMI 25-30 kg/m2 for overweight participants.
- •Body weight and eating habits stable in the last three months before the first visit.
- •Willingness to participate in the intervention study, giving their data and samples.
- •Signature and acceptance of the informed consent.
排除标准
- •Preexistence of other physical conditions (food allergy/sensitivity, gastrointestinal conditions [such as inflammatory bowel disease, celiac disease, pancreatitis, chronic constipation, etc.], immunodeficiency)
- •Eating disorders
- •Use of antibiotics one month prior to the first visit
- •Chronic use of medications (antacids, antidiabetics, anti-hypertensives, etc.)
- •History or current abuse of drugs or alcohol
- •Following a vegetarian, vegan, or other restrictive diet
- •Any other reason deemed appropriate for exclusion at the clinician's discretion
- •Non-compliance with adherence to treatment regimen
- •Direct association with research and/or investigators
结局指标
主要结局
Presence of our bacteria in feces
时间窗: Before the end of 2023
By specific PCR or by 16s sequencing
次要结局
- Adverse effect(Before the end of 2023)
研究者
Yolanda Sanz Herranz
Full Professor
Institute of Agrochemistry and Food Technology, National Research Council