| CTRI Number |
CTRI/2024/05/068125 [Registered on: 30/05/2024] Trial Registered Prospectively |
| Last Modified On: |
30/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How the gut bacteria changes in seriously ill patients admitted to intensive care units. |
|
Scientific Title of Study
|
Gut microbiome alterations in sepsis from a tertiary care hospital. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Archith Ravi Gowda |
| Designation |
Junior Resident |
| Affiliation |
Kasturba Medical College |
| Address |
Department of Microbiology 2nd Floor Basic Sciences Building Kasturba Medical College Manipal Udupi Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9901805890 |
| Fax |
|
| Email |
archithrg@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Director |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Directors Chamber,1st Floor, Manipal Institute of Virology MAHE, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Chiranjay Mukhopadhyay |
| Designation |
Director |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Directors Chamber,1st Floor, Manipal Institute of Virology MAHE, Manipal, Udupi, Karnataka 576104
Udupi
KARNATAKA
576104
India |
| Phone |
9845513057 |
| Fax |
|
| Email |
chiranjay.m@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Microbiology, Basic Sciences Building, Kasturba Medical College, Manipal, Udupi, Karntaka - 576104
Country: India |
|
|
Primary Sponsor
|
| Name |
Department of Microbiology Kasturba Medical College |
| Address |
Department of Microbiology 2nd Floor Basic Sciences Building Kasturba Medical College Manipal Udupi Karnataka 576104 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Directorate of Research |
Directorate of Research MAHE Udupi Karnataka 576104 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Archith Ravi Gowda |
Kasturba Medical College and Hospital |
Departments of Critical Care Medicine and Microbiology
Udupi
KARNATAKA |
9901805890
archthrg@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Comittee - 2 ( Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Nil premorbid. |
| Patients |
(1) ICD-10 Condition: A419||Sepsis, unspecified organism, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients hospitalized in intensive care units for sepsis.
Case definition:
Sepsis group:
· Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection.
· Organ dysfunction can be identified as an acute change in total SOFA score ≥2 points consequent to the infection.
· The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction.
Control group:
· Age matched individuals (± 5 years) with no known co-morbidities and living in the same locality as that of the sepsis group.
· No history of previous hospitalization in the past 6 months
· No history of consumption of antibiotics in the past 6 months. |
|
| ExclusionCriteria |
| Details |
Sepsis group:
Inability to obtain consent from the patient or next of kin.
Pregnant or breastfeeding women.
Age of the participant is less than 18 years.
Patients with "withdraw of care" decision at the time of inclusion.
Patients with restricted liberty or under legal protection.
Second admission to ICU or previous enrollment in a study (within same hospital admission).
Transfer from other hospital ICUs (if stay was greater than 24 hours).
Control group: History of hospitalisation and antibiotic consumption in the past 6 months. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Difference in gut microbiome diversity (Shanon and Observed index) between sepsis and control group.
Alteration in relative abundance of gut microbiome in sepsis patients. |
Assessment will done within 24 hours of admission to ICU and 4th day after admission to ICU. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• Difference in gut microbiome alpha diversity (Shannon index and Observed index) between sepsis and control groups.
• Alterations of the relative abundance of the gut microbiome among sepsis cases at different time points.
|
At end of study. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
15/06/2024 |
| 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="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Sepsis is a substantial yet underrecognized public health problem in India. With a population of over 130 crore people, India has one of the highest burdens of sepsis worldwide. However, there is a lack of high-quality epidemiological data on sepsis in India. The gut microbiome is thought to play a key role in sepsis risk and outcomes. Significant geographic variations in gut microbiome composition have been reported, attributed to differences in genetics, diet, environment, and early life exposures. Conducting this sepsis study in India would provide invaluable region-specific insights into the relationship between the gut microbiome and sepsis. Findings would pave the way for larger epidemiological studies to determine the sepsis burden in India more accurately. Elucidating unique gut microbiome signatures associated with sepsis progression in this population could reveal microbiome-related risk factors or prognostic indicators relevant to the Indian clinical context. Results could also inform the development of tailored diagnostic tools, preventive strategies, and microbiome-targeted therapies for sepsis management in India. In summary, this study will fill a major knowledge gap regarding the interplay between the gut microbiome and sepsis onset among critically ill patients in India.Our learnings can help improve sepsis prevention and care in this populous country with a disproportionately high sepsis rate.
|