To study the gut flora after traumatic brain injury.

Not yet recruiting

Conditions: Intracranial injury,

Registration Number: CTRI/2020/01/022731

Lead Sponsor: All India Institute of Medical Sciences AIIMS New Delhi

Brief Summary: The intestinal microbiome and brain function are related in a feedback loop in which component affects other. The gut microbiome is primarily composed of bacteroidetes and firmicutes with proteobacteria, Actinobacteria and fusobacteria in minor number. Preclinical data suggests that traumatic brain injury (TBI) induces an increase in intestinal permeability, which may lead to bacterial translocation, sepsis,and eventually multi-organ failure. Animal studies have shown changes in representative phyla and alpha-diversity significantly correlated with brain lesion volume. In humans, changes after TBI have still not been studied extensively. Growth of colistin resistant organisms is an emerging problem which needs to be recognised early for successful management of these patients. Thus, we plan to carry out this study with an aim to study the change in fecal microbiome profile after TBI and to also identify colistin resistant pathogens, if any.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 70

Inclusion Criteria

All patients of moderate-severe head injury admitted within 48 hours of injury.

Exclusion Criteria

Patients whose relatives refuse consent, have history of immune-suppression, viral markers positive, known case of irritable bowel disease and history of intake of selective gut disinfectants or any history of GI disturbance or GI surgery.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1.To study the profile of fecal microbiome after traumatic brain injury.	0, 3 and 7 day.
2.To study the temporal changes in microbiome after TBI	0, 3 and 7 day.

Secondary Outcome Measures

Name	Time	Method
To identify colonization with colistin resistence pathogens in these patients.

Trial Locations

Locations (1): All India Institute of Medical Sciences (AIIMS), New Delhi
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences (AIIMS), New Delhi
🇮🇳Delhi, DELHI, India
Charu Mahajan
Principal investigator
7042132730
charushrikul@gmail.com