Evolution of Oropharyngeal and Rectal Microbiota After Severe Traumatic Brain Injury

NCT03965611 | Active Not Recruiting

• 2 other identifiers: APHP1805372018-A02973-52
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Multiple Trauma

Keywords

Traumatic brain injury; Multiple trauma; Microbiota; Intensive care unit

Outcome Measures

Primary Outcomes (1)

• Change in microbiota alpha-diversity as measured by Shannon index

  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.

  From day 0 to day 90

Secondary Outcomes (5)

• Alpha and beta-diversities of oropharyngeal and rectal microbiota at different times post trauma.

  From day 0 to day 90

• ICU-acquired infections

  From day 0 to day 90

• Number of patients acquiring colonization or infection with multidrug resistant bacteria during ICU stay

  From day 0 to day 90

• Death at ICU discharge and 90 days post trauma.

  From day 0 to day 90

• Disability Rating Scale (DRS-F) score at 90 days post trauma

  From day 0 to day 90

Study Arms (3)

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; Procedure: Rectal swab; Procedure: Disability rating scale (DRS-F)

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; Procedure: Rectal swab; Procedure: Disability rating scale (DRS-F)

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; Procedure: Rectal swab

Interventions

Oropharyngeal swab PROCEDURE

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.

Healthy Controls; Patients with isolated severe traumatic brain injury (TBI); Patients with severe trauma without TBI

Rectal swab PROCEDURE

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.

Healthy Controls; Patients with isolated severe traumatic brain injury (TBI); Patients with severe trauma without TBI

Disability rating scale (DRS-F) PROCEDURE

Will be assessed at day 90 +/- 7 days.

Patients with isolated severe traumatic brain injury (TBI); Patients with severe trauma without TBI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are 18 years of age or older, admitted to intensive care unit for severe trauma.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Université Paris-Saclay: collaborator

Study Sites (1)

APHP Bicêtre Hospital

Le Kremlin-Bicêtre, 94270, France

Location

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.

MeSH Terms

Conditions

Brain Injuries, Traumatic; Multiple Trauma

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Samy Figueiredo, MD, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2019
• First Posted: May 29, 2019
• Study Start: April 21, 2019
• Primary Completion: January 2, 2023
• Study Completion: December 1, 2024
• Last Updated: May 30, 2024

Record last verified: 2024-05

Locations

FR (1)