NCT05949411招募中不适用
Development of Non-invasive Methods to Study Gut Microbiome - Nutrition - Host Interactions
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Exhaled volatile compounds
研究概览
简要总结
The aim of this study is to develop and validate an adequate protocol of volatolome (volatile metabolites) measurement in breath of human volunteers (18-65 years) to study gut microbiome - nutrition - host interactions in a general healthy population. For this purpose, breath volatile metabolites (BVM) will be analyzed throughout test days in fasting state and after standardized meals using selected ion flow tube mass spectrometry (SIFT-MS). In addition, gut microbial functions linked notably to hydrogen/methane production, carbohydrates utilization (CAZymes), and in the production of other volatile metabolites of interest (i.e. indole, fatty acid derivatives, ...) will be unraveled through microbiome sequencing data analysis (in silico), metabolomic analyses and measurement of enzymatic activities from saliva, urine and/or fecal samples.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Woman or man, aged of 18 to 65 years;
- •Body mass index (BMI) between 18 and 30 kg/m2;
- •Non-smoker;
- •Provision of signed and dated informed consent form;
- •Stated willingness to comply with all study procedures and availability for the duration of the study;
- •Speaking French.
排除标准
- •Subject with severe systemic disease (renal or hepatic failure, cancer, pancreatic cancer, chronic pancreatitis, asthma ...)
- •Subject with a history or current chronic/severe gastrointestinal disorder such as duodenal ulcer, chronic colitis, or chronic inflammatory disease of the digestive tract disease (Crohn's disease, ulcerative colitis), celiac disease or irritable bowel syndrome;
- •Subjects with a history of digestive tract surgery (except appendectomy);
- •Subject who had surgery within the two months prior to the study
- •Subjects with psychiatric problems and/or using antipsychotics
- •Current or recent (< 4 weeks) intake of antibiotics, fiber supplement, and/or any products modulating gut transit (laxative, anti-diarrheal, ...) or gut microbiota composition; these products will also be avoided for the duration of the study;
- •Chronic intake of drugs, except contraceptive drug;
- •Subject following a low-calorie diet and followed by a doctor or dietician in progress or recently (< 6 weeks);
- •Women of childbearing age who are pregnant or breastfeeding or who wish to become pregnant within the next 6 weeks or who are not using an adequate method of contraception (e.g. oral contraception, intrauterine device (IUD), abstinence, ...);
- •Subjects who drink more than 3 glasses of alcohol per day (> 30 g of alcohol per day);
- •Subjects having participated to another clinical trial two weeks before the screening test visit;
- •Subjects who practice an intense sport activity (more than 10 hours per week of intense activity);
- •Language barrier, mental or legal incapacity, unwillingness or inability to understand or not being able to participate to the study.
结局指标
主要结局
Exhaled volatile compounds
时间窗: Throughout the entire study, approximately during 24 months
Selected Ion flow tube mass spectrometry (SIFT-MS) - Area under the curve (calculated on 8 hours following breakfast ingestion)
次要结局
- Gastrointestinal symptom - discomfort(Throughout the entire study, approximately during 24 months)
- Exhaled hydrogen (H2)(Throughout the entire study, approximately during 24 months)
- Well-being(Throughout the entire study, approximately during 24 months)
- Gut microbiota(Throughout the entire study, approximately during 24 months)
- Exhaled methane (CH4)(Throughout the entire study, approximately during 24 months)
- Carbohydrates utilization - Carbohydrate active enzymes (CAZymes)(Throughout the entire study, approximately during 24 months)
- Gastrointestinal symptom - nausea(Throughout the entire study, approximately during 24 months)
- Gastrointestinal symptom - gastrointestinal reflux(Throughout the entire study, approximately during 24 months)
- Gastrointestinal symptom - cramps(Throughout the entire study, approximately during 24 months)
- Transit - frequency(Throughout the entire study, approximately during 24 months)
- Salivary microbiota(Throughout the entire study, approximately during 24 months)
- Gastrointestinal symptom - bloating(Throughout the entire study, approximately during 24 months)
- Gut microbiota metabolic capacity(Throughout the entire study, approximately during 24 months)
- Nutrient intake(Throughout the entire study, approximately during 24 months)
- Transit - ease of passage(Throughout the entire study, approximately during 24 months)
- Transit - level of emergency(Throughout the entire study, approximately during 24 months)
- Transit - empty feeling(Throughout the entire study, approximately during 24 months)
- Gastrointestinal symptom - flatulences(Throughout the entire study, approximately during 24 months)
- Gastrointestinal symptom - rumbling(Throughout the entire study, approximately during 24 months)
- Gastrointestinal symptom - burps(Throughout the entire study, approximately during 24 months)
- Exhaled carbon dioxide (CO2)(Throughout the entire study, approximately during 24 months)
- Dietary habits(Throughout the entire study, approximately during 24 months)
- Transit - type of stool(Throughout the entire study, approximately during 24 months)
研究者
研究点 (6)
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