Clinical trial NCT03011502: InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Official title: InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bone and Joint Infection
Lead sponsor: MaaT Pharma
Sponsor class: INDUSTRY
First posted: 2017-01-05
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.


Eligibility 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

Primary outcomes:
measure: Evolution of intensity and frequency of Diarrheic Symptoms
timeFrame: From baseline, up to 15 days after antibiotherapy treatment stop (Week 8 to week 14)
Secondary outcomes:
measure: Characterization of the gut dysbiosis and its prevalence in patients with BJI and under antibiotic treatment : measured by NGS (Next-Generation Sequencing) method
timeFrame: Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: CHU Bordeaux
city: Lyon
country: France
facility: HCL Croix-Rousse
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: GH Diaconesses-Croix Saint Simon
city: Tourcoing
country: France
facility: CH Tourcoing
Study officials:
affiliation: Hôpitaux civils de Lyon
name: Tristan Ferry, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: