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Evolution of Oropharyngeal and Rectal Microbiota After Severe Traumatic Brain Injury (BBAX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03965611
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : September 5, 2019
Sponsor:
Collaborator:
Paris-Saclay University
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief Summary:

Modifications of the human gut microbiota have been associated with different pathological conditions such as obesity, inflammatory bowel diseases and neurodegenerative diseases. Recently the " Brain-Gut Axis ", a bidirectional communication axis between brain and gut, has been described. In recent animal studies, an acute brain injury was associated with rapid modifications of the gut microbiota.

In humans, traumatic brain injury (TBI) is a leading cause of death and disability. The patterns of gut and oropharyngeal microbiota following TBI are unknown. The primary purpose of this study is to characterize gut and oropharyngeal microbiota of patients with severe TBI.


Condition or disease Intervention/treatment
Traumatic Brain Injury Multiple Trauma Procedure: Oropharyngeal swab Procedure: Rectal swab Procedure: Disability rating scale (DRS-F)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: From the Brain to the Bugs: Evolution of Oropharyngeal and Rectal Microbiota of Patients With Severe Traumatic Brain Injury Admitted in ICU
Actual Study Start Date : April 30, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Patients with isolated severe traumatic brain injury (TBI)
TBI with initial Glasgow Coma Scale (GCS) ≤ 8 and AISextrahead score ≤3. Oropharyngeal and rectal swabs will be performed for each patient within the first 24 hours after ICU admission (day 0), then 48 hours (day 2) and 7 days (day 7) after ICU admission and weekly thereafter until ICU discharge.
Procedure: Oropharyngeal swab
Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.

Procedure: Rectal swab
Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.

Procedure: Disability rating scale (DRS-F)
Will be assessed at day 90 +/- 7 days.

Patients with severe trauma without TBI
Patients with severe trauma without TBI (AISextrahead score > 3). Oropharyngeal and rectal swabs will be performed for each patient within the first 24 hours after ICU admission (day 0), then 48 hours (day 2) and 7 days (day 7) after ICU admission and weekly thereafter until ICU discharge.
Procedure: Oropharyngeal swab
Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.

Procedure: Rectal swab
Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.

Procedure: Disability rating scale (DRS-F)
Will be assessed at day 90 +/- 7 days.

Healthy Controls

Persons who have not had the conditions being studied or otherwise related conditions or symptoms, as specified in the eligibility requirements.

Oropharyngeal and rectal swabs will be taken only once, at inclusion, after that the participation of the control individual in the trial will be completed.

Procedure: Oropharyngeal swab
Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.

Procedure: Rectal swab
Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.




Primary Outcome Measures :
  1. Change in microbiota alpha-diversity as measured by Shannon index [ Time Frame: From day 0 to day 90 ]
    The oropharyngeal and rectal swabs, performed at day 0, day 2, day 7 after ICU admission and weekly thereafter until ICU discharge or no later than day 90, will be used for DNA extraction and the bacterial 16S rRNA amplification and sequencing in order to identify the bacterial species colonizing the gut.


Secondary Outcome Measures :
  1. Alpha and beta-diversities of oropharyngeal and rectal microbiota at different times post trauma. [ Time Frame: From day 0 to day 90 ]
    The oropharyngeal and rectal swabs, performed at day 0, day 2, day 7 after ICU admission and weekly thereafter until ICU discharge or no later than day 90, will be used for DNA extraction and the bacterial 16S rRNA amplification and sequencing in order to identify the bacterial species.

  2. ICU-acquired infections [ Time Frame: From day 0 to day 90 ]
    The ICU-acquired infection rates during the ICU stay

  3. Number of patients acquiring colonization or infection with multidrug resistant bacteria during ICU stay [ Time Frame: From day 0 to day 90 ]
    Multidrug resistant bacteria colonisation or infection acquired during the ICU stay

  4. Death at ICU discharge and 90 days post trauma. [ Time Frame: From day 0 to day 90 ]
    The rates of deaths at ICU discharge and 90 days post trauma

  5. Disability Rating Scale (DRS-F) score at 90 days post trauma [ Time Frame: From day 0 to day 90 ]
    Neurological outcome at 90 days post trauma evaluated by the Disability Rating Scale, the French translation (DRS-F) quoted from 0 (no disability) to 29 (extreme vegetative state)


Biospecimen Retention:   Samples With DNA

Biospecimen types :

  • Oropharyngeal swabs
  • Rectal swabs

The swabs will be performed for each patient within the first 24 hours after ICU admission (day 0), then 48 hours (day 2) and 7 days (day 7) after ICU admission and weekly thereafter until ICU discharge. Rectal and oropharyngeal swabs will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until bacterial DNA extraction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are 18 years of age or older, admitted to intensive care unit for severe trauma.
Criteria

Inclusion Criteria:

  • Admission to Bicêtre Hospital Trauma Center for severe trauma with:

either isolated severe traumatic brain injury (TBI): TBI with initial Glasgow Coma Scale (GCS) ≤ 8 and AISextrahead score ≤3; either severe trauma without TBI (AISextrahead score > 3)

  • Estimated ICU length of stay 48 hours or more

Exclusion Criteria:

  • Antimicrobial therapy within the previous 3 months
  • Long-term corticosteroids use
  • Active cancer
  • Institutionalized patient
  • Gastro-intestinal perforation or emergency gastro-intestinal surgery following trauma
  • Withdrawal of consent
  • Patient under guardianship
  • Pregnant or breastfeeding women

Information from the National Library of Medicine

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): NCT03965611


Contacts
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Contact: Samy Figueiredo, MD, PhD +33 (0)145213441 samy.figueiredo@aphp.fr

Locations
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France
APHP Bicêtre Hospital Recruiting
Le Kremlin-Bicetre, France, 94270
Contact: Samy FIGUEIREDO, MD, PhD    +33 (0)145213441    samy.figueiredo@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Paris-Saclay University
Investigators
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Principal Investigator: Samy Figueiredo, MD, PhD Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03965611     History of Changes
Other Study ID Numbers: APHP180537
2018-A02973-52 ( Other Identifier: IDRCB )
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Traumatic brain injury
Multiple trauma
Microbiota
Intensive care unit
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Multiple Trauma
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System