| CTRI Number |
CTRI/2020/01/022731 [Registered on: 13/01/2020] Trial Registered Prospectively |
| Last Modified On: |
02/01/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the gut flora after traumatic brain injury. |
|
Scientific Title of Study
|
To study the characteristics of gut microbiome after traumatic brain injury. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charu Mahajan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
Seventh floor,Neurosciences centre AIIMS
New Delhi
DELHI
110029
India |
| Phone |
7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charu Mahajan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
Seventh floor,Neurosciences centre AIIMS
New Delhi
DELHI
110029
India |
| Phone |
7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charu Mahajan |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
Department of Neuroanaesthesiology and Critical Care
Seventh floor,Neurosciences centre AIIMS
New Delhi
DELHI
110029
India |
| Phone |
7042132730 |
| Fax |
|
| Email |
charushrikul@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, New Delhi. |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences AIIMS New Delhi |
| Address |
Dept. of Neuroanaesthesiology and Critical Care, All India Institute of Medical Sciences, AIIMS New Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Charu Mahajan |
All India Institute of Medical Sciences (AIIMS), New Delhi |
Trauma NeuroICU, third floor Jai prakash Narayan Apex Trauma Center, AIIMS, New Delhi.
New Delhi
DELHI |
7042132730
charushrikul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S06||Intracranial injury, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients of moderate-severe head injury admitted within 48 hours of injury. |
|
| ExclusionCriteria |
| Details |
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 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.To study the profile of fecal microbiome after traumatic brain injury.
2.To study the temporal changes in microbiome after TBI
|
0, 3 and 7 day.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify colonization with colistin resistence pathogens in these patients.
|
0, 3 and 7 day. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/01/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
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. |