Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection (GUMIBONE)
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| ClinicalTrials.gov Identifier: NCT03633188 |
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Recruitment Status :
Terminated
(the study had to be stopped because the period of the Financial contract was over)
First Posted : August 16, 2018
Last Update Posted : February 5, 2021
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Bone and joint infections (BJI) is a public health issue in industrialized countries.
Implant-associated BJI, are complex hospital-acquired infections and eradication of the pathogen is challenging in such patients.
A prolonged antimicrobial therapy is usually required from 6 weeks to 3 months, but some patients are eligible to several years of treatment and most of patients report gastrointestinal troubles, such as nausea and mild to severe diarrhea (but very few developed C. difficile diarrhea).
Moreover, the host gut microbiota is probably largely affected in abundance, richness and diversity. Indeed, it is known, that few days of antibiotics are sufficient to induce significant alterations of the gut microbiota, also called dysbiosis.
Severe dysbiosis, which is potentially irreversible and associated with a definitive shift in the gut microbiota metabolism and host homeostasis, may lead to and/or promote a large panel of severe diseases such as Clostridium difficile infection, diabetes mellitus, obesity, inflammatory bowel disease (IBD), cirrhosis, neurological disorders and cancer. It may also be associated with BJI recurrence and then impact global health costs.
The main objective of this study is to constitute biobanking of stools and perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Infection, Bacterial | Biological: Patients treated by antibiotherapy | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 12 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Basic Science |
| Official Title: | Stool Biobanking and Impact of Antimicrobials on the Gut Microbiota in Patients With Bone and Joint Infection |
| Actual Study Start Date : | July 19, 2018 |
| Actual Primary Completion Date : | August 28, 2020 |
| Actual Study Completion Date : | August 28, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Patients treated by antibiotherapy
35 Patients treated by antibiotherapy for acute and subacute post-operative implant-associated BJI infections and among them 10 patients with Staphylococcus. aureus treated with antibiotics as part of their standard treatment procedure for metagenomic procedure.
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Biological: Patients treated by antibiotherapy
Biological samples (stool, blood, swabs) will be collected :
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- change in the gut microbiota after treatment [ Time Frame: from baseline to week 26 ]
stools will be collected to perform DNA sequencing of the gut microbiota in patients with acute or sub-acute implant-related Bone and Joint Infection (BJI), caused by Staphylococcus aureus.
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
- Assessment of the evolution of intensity of Diarrheic Symptoms [ Time Frame: from baseline to week 8 or week 26 ]intensity of diarrheic symptoms will be collected at baseline, at the end of treatment (Week 6 or Week 24) and 15 days after antibiotic stop (Week 8 or Week 26)
- Assessment of the evolution of frequency of Diarrheic Symptoms [ Time Frame: from baseline to week 8 or week 26 ]frequency of diarrheic symptoms will be collected at baseline, at the end of treatment (Week 6 or Week 24) and 15 days after antibiotic stop (Week 8 or Week 26)
- Quantity of rectal acquisition of Multi Drug Resistance (MDR) bacteria under antibiotics measured by classic culture and quantification culture methods [ Time Frame: at week 6 or week 24 ]
classic culture and quantification culture methods determined by microbiology analysis of the feces.
Feces will be collected at baseline and at the end of treatment
- gut dysbiosis measured by Next Generation Sequencing (NGS) [ Time Frame: from baseline to week 26 ]
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
Microbiota sequencing will be done after DNA extraction. Composition of the microbiota will be screened in feces samples using the shotgun sequencing method to establish a total picture of the gut composition and diversity as well as evolution of the microbiome.
- severe post-antibiotic dysbiosis (SPAD) measured by Next Generation Sequencing (NGS) [ Time Frame: from baseline to week 26 ]
Severe Post-Antibiotic Dysbiosis lead to irreversible change in gut microbiota status and systemic consequences for the host.
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
- Identification of markers of the gut dysbiosis (inflammatory proteins) measured by Elisa techniques [ Time Frame: from baseline to week 26 ]
ELISA techniques will be used to determine the concentration of 3 specific inflammatory stool epithelium proteins: zonulin, calprotectin and neopterin.
Stools will be collected at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
- Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D5L questionnaires [ Time Frame: from baseline to week 26 ]
EQ-5D questionnaire has 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression". All dimensions are described by 5 (EQ-5D-5L) problem levels corresponding to patient response choices.
Questionnaire will be completed at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
- Analysis of impact of Bone and Joint Infection on health-related quality of life in patients by EQ5D3L questionnaire [ Time Frame: from baseline to week 26 ]
EQ-5D questionnaire has 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression". All dimensions are described by 3 (EQ-5D-3L) problem levels corresponding to patient response choices. In France, only the EQ-5D-3L has been validated, not yet the EQ-5D-5L which has only been translated.
Questionnaire will be completed at baseline, during antibiotic treatment (Week 2), at the end of treatment (Week 6 or Week 24),15 days after antibiotherapy stop (Week 8 or Week 26), and W26 after baseline.
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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:
- The subject is willing, able to understand and comply to the protocol requirement
- More than 18-years-old
- Subject with suspicion of implant-related BJI within 3 months after surgery and treated by antibiotherapy for a maximal duration of six months
- Subject signed Inform Consent Form
- Contraception for women of childbearing age
Exclusion Criteria:
- Pregnancy
- Severe disease with a life expectancy < 3months
- Any antibiotherapy treated all diseases in the 14 days before inclusion
- Guardianship, curatorship patients
- Patient non-affiliated to health care system
- Patient under the power of law
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): NCT03633188
| France | |
| Hôpital de la Croix Rousse-Service de chirurgie orthopédique | |
| Lyon, France, 69004 | |
| Hôpital de la Croix Rousse-Service des Maladies Infectieuses et Tropicales | |
| Lyon, France, 69004 | |
| Centre Hospitalier Lyon Sud-Service de Chirurgie Orthopédique | |
| Pierre Benite, France, 69310 | |
| Centre Hospitalier Lyon Sud-Service des maladies infectieuses | |
| Pierre Bénite, France, 69310 | |
| Principal Investigator: | Tristan FERRY, Pr | Hospices Civils de Lyon |
| Responsible Party: | Hospices Civils de Lyon |
| ClinicalTrials.gov Identifier: | NCT03633188 |
| Other Study ID Numbers: |
69HCL17_0652 2017-A02813-50 ( Other Identifier: ANSM ) |
| First Posted: | August 16, 2018 Key Record Dates |
| Last Update Posted: | February 5, 2021 |
| Last Verified: | February 2021 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Bone and Joint Infections (BJI) gut dysbiosis antimicrobial resistance antibiotic resistance gene mobile genetic elements |
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Infections Communicable Diseases Bacterial Infections |
Disease Attributes Pathologic Processes Bacterial Infections and Mycoses |