InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS (OSIRIS)
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| ClinicalTrials.gov Identifier: NCT03011502 |
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Recruitment Status :
Completed
First Posted : January 5, 2017
Last Update Posted : April 5, 2018
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Bone and Joint Infection | Other: Biological samples collection of blood and feces | Not Applicable |
| 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 |
| Arm | Intervention/treatment |
|---|---|
| Experimental: Experimental arm |
Other: Biological samples collection of blood and feces |
- 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)
- 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) ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| 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 | |
| Principal Investigator: | Tristan Ferry, MD, PhD | Hôpitaux civils de Lyon |
| 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 |