Ensayo Exploratorio Para Evaluar la Tolerancia de Una Bacteria Con Potencial probiótico (Phascolarcobacterium Faecium) de Nueva generación Para Proteger la Salud metabólica en Humanos
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of adverse events and general health status
研究概览
简要总结
The goal of this interventional study is to assess the safety and tolerability of the daily administratrion of bacterium Phascolarctobacterium faecium in healthy adults with normal weight, and in individuals with overweight and alterations in glucose metabolism. The main questions this study aims to answer are:
Is the bacterium intake safe? Is the bacterium intake well tolerated? The objecitves are to assess if the intake of the bacterium is well tolerated by assessing gastrointenstinal symptoms, and safe, by assessing biochemical markers, incidence of adverse events and the general health status.
Participants will take daily the bacterium for 15 days. Study assessments include stool collection for microbiota analysis; blood sampling form biochemical tests, anthropometric measurements, and validated questionnaires on diet, physical activity, and perceived health.
详细描述
A total of 20 adult volunteers will consume a daily dose of Phascolarctobacterium faecium once per day for 15 consecutive days. Stool and blood samples will be collected at baseline and after the intervention; blood draws will be performed following an overnight fasting of at least 8 hours. Participants will also complete online questionnaires assessing sociodemographic characteristics, gastrointestinal symptoms, bowel habits, general health status, physical activity, and dietary habits. In addition, body composition parameters will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •18-65 years
- •stable body weight and dietary habits during the previous three months
- •written informed consent
排除标准
- •the presence of gastrointestinal disorders
- •immunodeficiency
- •eating disorders
- •antibiotic use within one month before the study
- •chronic antidiabetic therapy
- •substance (drug) abuse
- •restrictive diets
- •any other condition deemed inappropriate for participation by the clinician
结局指标
主要结局
Incidence of adverse events and general health status
时间窗: 21 days
Participants will have access to a 24-hour contact number to report any inconvenience or adverse effects. All adverse effects will be recorded throughout the intervention period and for one additional week after completion. Outcomes will be reported as the presence or absence of adverse effects.
Systemic safety of P. faecium intake assessed in all the clinical trial participants by biochemical markers
时间窗: 15 days
Complete hemogram and biochemical analysis will be permormed at baseline and after bacterum intervention and includes red blood cells, white blood cells, and assessments of lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, and non-HDL cholesterol), renal function (urea, creatinine, and uric acid), hepatic function (total protein, AST, and ALT), and glucose homeostasis (glucose, insulin, HbA1c, and HOMA-IR). All parameters will be measured using standard units commonly applied in clinical practice, and results will be compared before and after the intervention. It will be interpreted as either unchanged or altered relative to baseline values.
Tolerability assessment measured by stool habit
时间窗: 15 days
To assess the tolerability of P. faecium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, capturing both weekly bowel movement frequency and stool consistency using the Bristol Stool Scale. Stool habits will be evaluated by integrating these two variables: a normal habit will be defined as 4-14 bowel movements per week together with a Bristol score of 3-5, whereas any deviation from these ranges will be classified as an altered stool habit.
Tolerability assessment measured by the frequency of heartburn.
时间窗: 15 days
Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of heartburn. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.
Tolerability assessment measured by the frequency of abdominal bloating.
时间窗: 15 days
Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of abdominal bloating. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.
Tolerability assessment measured by the frequency of constipation.
时间窗: 15 days
Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of constipation. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.
Tolerability assessment measured by the frequency of diarrhea.
时间窗: 15 days
Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of diarrhea. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.
Tolerability assessment measured by the frequency of nausea.
时间窗: 15 days
Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of nausea. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.
Tolerability assessment measured by the frequency of flatulence.
时间窗: 15 days
Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of flatulence. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.
次要结局
未报告次要终点
研究者
Yolanda Sanz Herranz
Professor
Spanish National Research Council