Search Cytomegalovirus (CMV) in Healthy Volunteers Stools Samples Selected as Potential Donor for Fecal Microbiota Transplant
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 5
- 主要终点
- Detection frequency of CMV
研究概览
简要总结
Fecal microbiota transplantation (FMT) is recommended in the treatment of recurrent Clostridium difficile infection (CDI). The principle is to administer a fecal suspension of a healthy subject (donor) in the digestive tract of a patient with an CDI (receiver). Donors are being clinical and laboratory screening to reduce the likelihood of pathogens transmission (infectious and other). Cytomegalovirus (CMV) is part of the examinations requested by the Agence national de sécurité du médicament et des produits de santé in the context of clinical research. A sero-matching between donor and recipient CMV is requested. This recommendation eliminates many potential donors to a recipient. To date, the frequency detection level of CMV in stool in healthy volunteers with documented positive CMV serology is not known. In addition, CMV transmission risk via the stool is not established. This study aims to determine the detection frequency of CMV in healthy volunteers stool samples selected as potential donors for a FMT and having a positive CMV serology documented
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Men and women aged over 18 and under 65 years
- •Having a normal transit (less than three stools per day and more than three bowel movements per week)
- •Body mass index (BMI) <30 and> 16.9
- •Accept the constraints of the study, ie two visits (inclusion and Following Visit), a stool sample, two blood tests
- •Having given and signed informed consent
- •Being affiliated or beneficiary of a social security scheme
排除标准
- •Taking a treatment with anti-CMV action in three months by acyclovir, valacyclovir, ganciclovir, valganciclovir, foscarnet, cidofovir, brincidofovir
- •Having an absolute exclusion criteria to donation defined by the survey of French Group Fecal Transplant:
- •Digestive disorders (acute or chronic diarrhea) in the three months prior to donation
- •Known chronic disease (except hypertension and hypercholesterolemia)
- •Documented history of typhoid fever
- •Taking long-term medication (except contraceptives, cholesterol-lowering and antihypertensive treatment)
- •Antibiotic taken within three months
- •Stay in tropics during the three months prior to donation,
- •Residence of several years in tropics (over 24 months)
- •Hospitalization abroad of more than 24 hours in the last 12 months to the donor or his entourage (those living under the same roof)
- •Healthy Volunteers who have not reached the limit of compensation by social security or exclusion period
研究组 & 干预措施
Healthy volunteers
For healthy volunteers corresponding to the inclusion criteria it will be taken them Blood and stool samples : a blood sample during the inclusion visit and if they are seropositive for the CMV, it will be taken them another blood sample and they will give a stool sample for the following visit
干预措施: Blood and stool samples (Other)
结局指标
主要结局
Detection frequency of CMV
时间窗: 30 days
Detection frequency of CMV in healthy volunteers stool samples with the selection criteria for the gift of fecal microbiota and having a CMV positive serology
次要结局
- Infectivity of CMV present in faecal(At day 30)
- Presence of CMV in the stool and in blood.(At day 30)