InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS (OSIRIS)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Bone and Joint Infection	Other: Biological samples collection of blood and feces	Not Applicable

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	62 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Screening
Official Title:	InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Study Start Date :	December 2016
Actual Primary Completion Date :	March 27, 2018
Actual Study Completion Date :	March 27, 2018

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Experimental arm	Other: Biological samples collection of blood and feces

Outcome Measures

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Primary Outcome Measures :

1. Evolution of intensity and frequency of Diarrheic Symptoms [ Time Frame: 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 :

1. Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method [ Time Frame: Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months) ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

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, France

Sponsors and Collaborators

MaaT Pharma

Investigators

Principal Investigator:	Tristan Ferry, MD, PhD	Hôpitaux civils de Lyon

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	MaaT Pharma
ClinicalTrials.gov Identifier:	NCT03011502 History of Changes
Other Study ID Numbers:	MPBJI01
First Posted:	January 5, 2017
Last Update Posted:	April 5, 2018
Last Verified:	November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes

Additional relevant MeSH terms:

Infection; Communicable Diseases; Arthritis, Infectious; Dysbiosis	Arthritis; Joint Diseases; Musculoskeletal Diseases; Pathologic Processes