Ex-vivo Evaluation of the Effect of 2 Probiotic Solutions (Lactibiane ATB and Lactibiane Enfant) and 5 Classes of Drugs on the Intestinal Microbiota
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Larena SAS
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Metabolites produced and microbial metabolic pathways
研究概览
简要总结
The objective is to test ex-vivo the effects of two probiotic solutions (Lactibiane ATB and Lactibiane Enfant) and five classes of drugs (antibiotic, proton pump inhibitor, non-steroidal anti-inflammatory, anxiolytic and anti-depressant) on microbial microcosms derived from human stool samples (from adults and children) re-cultured under anaerobic conditions.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult "Mother" population:
- •Women aged 25-40 years;
- •In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or long-term treatment,
- •With a regular bowel movement frequency (at least once every 2 days)
- •BMI between 18.5 and 25
- •Able and willing to participate in the research by complying with the protocol procedures
- •Not objecting to the collection and processing of their personal data
- •Child "Daughter" population
- •Girl between 1 and 2 years old
- •In good general health, i.e. no chronic pathology and not taking any medication at the time of inclusion and/or on a long-term basis,
- •With a regular stool frequency (at least once every 2 days)
- •Whose mother does not object to the collection and processing of personal data
排除标准
- •Adult "Mother" population :
- •Pregnant or breastfeeding women,
- •Under antibiotic treatment, or having stopped it for less than a month.
- •Under dietary supplementation (prebiotics or probiotics) or having stopped it less than one month before
- •On antidepressants and/or anxiolytics in the month before inclusion
- •Taking a non-steroidal anti-inflammatory drug (NSAID) the month before inclusion.
- •On PPI, or having stopped it less than one month before.
- •Persons under court protection,
- •Person participating in another research study with an ongoing exclusion period,
- •Child "Daughter" population:
- •Outside the WHO normal growth charts (weight for height) for girls aged 0-2 years (below the 3rd percentile or above the 97th percentile)
- •Undergoing antibiotic treatment, or having stopped it less than a month ago.
- •Having taken a non-steroidal anti-inflammatory drug (NSAID) in the month prior to inclusion.
- •On dietary supplements (prebiotics or probiotics) or having stopped them within the last month
- •Subjects participating in another research study with an ongoing exclusion period
结局指标
主要结局
Metabolites produced and microbial metabolic pathways
时间窗: 10 months
Metabolites produced and microbial metabolic pathways will be assessed by global metabolomics
Transcriptomic profiles of the communities
时间窗: 10 months
Transcriptomic profiles of the communities assessed by meta-transcriptomics
Transcriptional activity of microbiomes
时间窗: 10 months
Transcriptional activity of microbiomes by sequencing of 16S rRNA vs. the gene encoding 16S rRNA
次要结局
未报告次要终点