| Registry | NCT03011502, acronym OSIRIS |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; na, single group, masking: none, screening |
| Enrollment | 62 (Actual) |
| Sponsor | MaaT Pharma (Industry) |
| Conditions | Bone and Joint Infection |
| Interventions | Biological samples collection of blood and feces (Other) |
| Dates | start 2016-12-01, primary completion 2018-03-27, completion 2018-03-27, first posted 2017-01-05, last updated 2018-04-05 |
| Locations | 5 sites in France |
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All trials for Bone and Joint Infection All trials of Biological samples collection of blood and feces
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental arm | Experimental | Other: Biological samples collection of blood and feces |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * 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 Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| CHU Bordeaux | Bordeaux | France | |
| HCL Croix-Rousse | Lyon | France | |
| CHU de Nantes | Nantes | France | |
| GH Diaconesses-Croix Saint Simon | Paris | France | |
| CH Tourcoing | Tourcoing | France |