InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

Bone and Joint Infection Clinical Trial

— OSIRIS  

Official title:

InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011502
• Other study ID #: MPBJI01
• Status: Completed
• Phase: N/A
• First received: December 27, 2016
• Last updated: April 4, 2018
• Start date: December 2016
• Est. completion date: March 27, 2018

Study information

• Verified date: November 2017
• Source: MaaT Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: March 27, 2018
• Est. primary completion date: March 27, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis, Infectious
• Bone and Joint Infection
• Communicable Diseases
• Dysbiosis
• Infection

Intervention

Other:
• Biological samples collection of blood and feces

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux
France	HCL Croix-Rousse	Lyon
France	CHU de Nantes	Nantes
France	GH Diaconesses-Croix Saint Simon	Paris
France	CH Tourcoing	Tourcoing

Sponsors (1)

Lead Sponsor	Collaborator
MaaT Pharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)