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

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ClinicalTrials.gov Identifier: NCT03011502
Recruitment Status : Completed
First Posted : January 5, 2017
Last Update Posted : April 5, 2018
Sponsor:
Information provided by (Responsible Party):
MaaT Pharma

Study Description
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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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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, Older Adult)
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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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011502


Locations
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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
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Principal Investigator: Tristan Ferry, MD, PhD Hôpitaux civils de Lyon
More Information
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Responsible Party: MaaT Pharma
ClinicalTrials.gov Identifier: NCT03011502     History of Changes
Other Study ID Numbers: MPBJI01
First Posted: January 5, 2017    Key Record Dates
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:
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Infection
Communicable Diseases
Arthritis, Infectious
Dysbiosis
 Arthritis
Joint Diseases
Musculoskeletal Diseases
Pathologic Processes