MedTrace Logo

Evolution of Oropharyngeal and Rectal Microbiota After Severe Traumatic Brain Injury

NCT03965611 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2024-05-30

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Université Paris-Saclay

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Samy Figueiredo, MD, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-21
Primary Completion
2023-01-02
Completion
2024-12-31

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03965611 on ClinicalTrials.gov