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Completed

NCT Number: NCT03011502

InterventiOnal Study of Bone and Joint Infections Related Gut dysbiosIS

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.

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Key information

Conditions

Bone and Joint Infection

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Bordeaux, Bordeaux, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biological samples collection of blood and feces

Other

Primary outcomes

  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 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

    Time frame: Between baseline, after antibiotherapy treatment stop (Week 8-14) and the end of the follow-up (6 months)

Sponsors and collaborators

Lead sponsor

MaaT Pharma

Industry

Registry information

Acronym: OSIRIS

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 5, 2017
Registry last updated
Apr 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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