Profiling Fecal Samples to Optimize Selection of Stool Donors for Fecal Microbiota Transplantation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Dosage of fecal samples with search for differentiated fecal profiles.
研究概览
简要总结
Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis .... A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure.
详细描述
Fecal microbiota transplantation (FMT) represents a promising therapeutic in numerous clinical situations associated with dysbiosis. Today, this procedure is recommended in patients with recurrent Clostridioides difficile infections but beneficial effects of FMT have also been described in other diseases associated with intestinal dysbiosis .... A donor effect which could be related to the inter-individual variability of microbiota and microbiome leading to specific metabolic capacities may influence the efficacy of the procedure. The aim of our study is to measure fecal biochemical, microbial and immunological parameters that are known to influence gut homeostasis in a group of 40 healthy donors to establish a referential profile of human stools to optimize donor profiling, beyond the infectious parameters, to increase the success rate of FMT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age ≥ 18 years
- •Healthy volunteers
- •Participant having been informed of the study and having sign a consent to participation
- •Patient affiliated with a social security or beneficiary of such a social protection
排除标准
- •Person subject to legal protection (guardianship, trusteeship, etc.)
- •Chronic disease that can alter the intestinal microbiota: cancer or malignant disease, bowel disease, diabetes, hypertension, hypercholesterolemia, ....
- •Presence in the 1st degree family of one of the chronic diseases mentioned above
- •Blood in stools
- •Chronic drug treatment likely to alter the intestinal microbiota
- •Travel to a tropical country in the last 3 months or extended stay (> 3 months) for less than 1 year
- •Hospitalization abroad (> 24h) in the last 12 months
- •Hospitalization abroad (> 24h) of a family member living under the same roof during the last 12 months
- •Medical consultation in the last 3 months (other than administrative)
- •Contact with a person with an infectious or contagious disease for more than 3 months
- •Digestive disorders / febrile gastroenteritis (diarrhea with fever) in the last 3 months
- •Febrile illnesses for more than 3 months
- •Antibiotic treatment in the last 3 months
- •Treatment with PPIs in the last 3 months
研究组 & 干预措施
healthy controls
Questionnaire and fecal sample collection
干预措施: Questionnaire and fecal sample collection (Other)
结局指标
主要结局
Dosage of fecal samples with search for differentiated fecal profiles.
时间窗: At 12 months
16S genomic analysis of microbiota will be performed for the evaluation of alpha and beta diversities of microbiota. Results will be aggregated to define differentiated faecal profiles in healthy volunteers.
次要结局
- Dosage of fecal biomarkers with search for differentiated fecal profiles.(At 12 months)
- Quantification of colonic inflammation in mouse model.(At 15 months)