InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 5
- 主要终点
- Evolution of intensity and frequency of Diarrheic Symptoms
研究概览
简要总结
Gut dysbiosis is an intestinal disorder that is characterized by accumulation of microbiota imbalance, host-microbiota crosstalk dysfunction and inflammation.
As part of its clinical development, MaaT (Microbiota as a Therapy) Pharma is particularly interested in patients with Bone and Joint Infections (BJI). These patients are treated with antibiotics having significant consequences on their intestinal flora, causing intestinal discomfort, which can be manifested by diarrhea.
MaaT Pharma wishes to carry out a clinical study, OSIRIS, in collaboration with Prof. Tristan Ferry, member and coordinator of CRIOAc (Centre de Référence des Infections Ostéo-Articulaires Complexes) Lyon, Center of Reference of Bone and Joint Infections (BJI). The objective of this study is to follow patients with treated BJI in order to characterize intestinal dysbiosis and the future relevance of an autologous Fecal Microbiota Transplantation (aFMT) intervention.
To do this, patients will be monitored according to the current CRIOAc recommendations, with the aim of taking biological samples from patients at the same time as scheduled visits, routine monitoring patients. Only one additional consultation will be carried out 15 days after stopping the antibiotics in order to better evaluate the dysbiosis evolution.
Thus biological samples (blood, stool, nasal, rectal) will be taken during the follow-up consultations over a period of 6 months.
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
- 否
入选标准
- •Consenting subjects with BJI (native or material related BJI) at participating sites who are being treated with antibiotics as part of their standard treatment procedure will be enrolled
- •The subject is willing, able to understand and comply to the protocol requirement
- •More than 18-years-old
- •Subject is suspected for implanted or native BJI and is eligible for antibiotics treatment
- •Subject signed Inform Consent Form
排除标准
- •Pregnancy
- •Severe disease with a life expectancy < 3 months
- •Antibiotherapy in the 14 days before inclusion in the study
- •Patient non-affiliated to health care system
- •Patient under the power of law
- •Guardianship, curators patients
结局指标
主要结局
Evolution of intensity and frequency of Diarrheic Symptoms
时间窗: From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)
Assessment of the evolution of intensity and frequency of Diarrheic Symptoms from baseline, during antibiotic treatment (W2), at the end of treatment (W6-12) and 15 days after antibiotherapy treatment stop (W8-14)
次要结局
- Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method(Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months))