NCT03011502

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

December 27, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 5, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2018

Completed
Last Updated

April 5, 2018

Status Verified

November 1, 2017

Enrollment Period

1.3 years

First QC Date

December 27, 2016

Last Update Submit

April 4, 2018

Conditions

Bone and Joint Infection

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • 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)

Study Arms (1)

Experimental arm

EXPERIMENTAL
Other: Biological samples collection of blood and feces

Interventions

Biological samples collection of blood and fecesOTHER
Experimental arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pregnancy
  • Severe disease with a life expectancy \< 3 months
  • Patient non-affiliated to health care system
  • Patient under the power of law
  • Guardianship, curators patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU Bordeaux

Bordeaux, France

Location

HCL Croix-Rousse

Lyon, France

Location

CHU de Nantes

Nantes, France

Location

GH Diaconesses-Croix Saint Simon

Paris, France

Location

CH Tourcoing

Tourcoing, France

Location

MeSH Terms

Interventions

Defecation

Intervention Hierarchy (Ancestors)

Digestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Tristan Ferry, MD, PhD

    Hôpitaux civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 27, 2016

First Posted

January 5, 2017

Study Start

December 1, 2016

Primary Completion

March 27, 2018

Study Completion

March 27, 2018

Last Updated

April 5, 2018

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will share

Locations

FR(5)