InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

Not Applicable

Completed

• Conditions: Bone and Joint Infection
• Interventions: Other: Biological samples collection of blood and feces

• Registration Number: NCT03011502
• Lead Sponsor: MaaT Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12
• Study First Submitted: 2016-12-27
• Study First Submitted QC: 2017-01-03
• Study First Posted: 2017-01-05
• Status Verified: 2017-11
• Primary Completion: 2018-03-27
• Study Completion: 2018-03-27
• Last Update Submitted: 2018-04-04
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental arm	Biological samples collection of blood and feces	-

Primary Outcome Measures

Name	Time	Method
Evolution of intensity and frequency of Diarrheic Symptoms	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)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (5)

HCL Croix-Rousse; 🇫🇷 Lyon, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

GH Diaconesses-Croix Saint Simon; 🇫🇷 Paris, France

CHU de Nantes; 🇫🇷 Nantes, France

CH Tourcoing; 🇫🇷 Tourcoing, France