InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

Study Overview
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Brief Summary
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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.

Official Title
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InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

Conditions
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Bone and Joint Infection

Intervention / Treatment
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* Other: Biological samples collection of blood and feces


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental arm<br> | Other: Biological samples collection of blood and feces<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of intensity and frequency of Diarrheic Symptoms | 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) | From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |