| CTRI Number |
CTRI/2022/05/042815 [Registered on: 25/05/2022] Trial Registered Prospectively |
| Last Modified On: |
01/10/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Epidemiological Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Estimation of prevalence of Inflammatory bowel disease in Punjab |
|
Scientific Title of Study
|
A population based epidemiological study of inflammatory bowel disease in Punjab India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajit Sood |
| Designation |
Professor |
| Affiliation |
Dayanand medical college and hospital |
| Address |
Dayanand Medical College and Hospital,, Tagore Nagar, Civil Lines, Ludhiana
Tagore Nagar, Civil Lines, Ludhiana Tagore Nagar, Civil Lines, Ludhiana Ludhiana PUNJAB 141001 India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ajit Sood |
| Designation |
Professor |
| Affiliation |
Dayanand medical college and hospital |
| Address |
Dayanand Medical College and Hospital,, Tagore Nagar, Civil Lines, Ludhiana
Tagore Nagar, Civil Lines, Ludhiana Tagore Nagar, Civil Lines, Ludhiana Ludhiana PUNJAB 141001 India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Ajit Sood |
| Designation |
Professor |
| Affiliation |
Dayanand medical college and hospital |
| Address |
Dayanand Medical College and Hospital,, Tagore Nagar, Civil Lines, Ludhiana
Tagore Nagar, Civil Lines, Ludhiana Tagore Nagar, Civil Lines, Ludhiana Ludhiana PUNJAB 141001 India |
| Phone |
9815400718 |
| Fax |
|
| Email |
ajitsood10@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dayanand Medical College and Hospital, Ludhiana, Punjab |
|
|
Primary Sponsor
|
| Name |
Dayanand Medical College and Hospital |
| Address |
Tagore Nagar, Civil Lines, Ludhiana, Punjab |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Dr Ajit Sood |
Dayanand Medical College and Hospital |
Department of Gastroenterology, Third Floor, DMCH Ludhiana PUNJAB |
9815400718
ajitsood10@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K508||Crohns disease of both small andlarge intestine, (2) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Any individual with chronic diarrhea (more than 4 weeks) with/ without rectal bleeding |
|
| ExclusionCriteria |
| Details |
Individuals with normal stool frequency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Environmental influences exert important roles on the pathogenesis and natural history of IBD. This study aims to provide key mechanistic insights into how environmental and lifestyle influences may modify susceptibility to IBD. |
6 months-Ethical clearances, recruitment of man power
6-24 months-Data collection, recruitment of patients, Feacel calprotecnin, colonoscopy/sigmoidoscopy, rectal biopsy CT enterography
24-36 months-Data and result compilations
Writing publications.
Critical evaluation of the project and project report writing and submission
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To estimate the prevalence of IBD (Ulcerative colitis and Crohn’s Disease) in Punjab (India).
2.To access the role of environmental factors as a risk factor in the development of IBD.
|
6 months Ethical cleareance, recruitment of man power
6-24 months Data collection, recruitment of patients, Feacel calprotecnin, colonoscopy/sigmoidoscopy, rectal biopsy, CT enterography
24-36 months Data and result compilations
Writing publications.
Critical evaluation of the project and project report writing and submission
|
|
|
Target Sample Size
|
Total Sample Size="500" Sample Size from India="500"
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)
|
01/06/2022 |
| 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="3" Months="0" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: The incidence/prevalence
rates of Inflammatory Bowel Disease (IBD) are rising in Asian countries with
India probably topping the list. Improved physician awareness and better
diagnostic modalities lone are not likely to account fully for this rise.
Clinical and experimental evidence supports an association between IBD and a
large number of seemingly unrelated environmental factors, which include
smoking, improved sanitation, westernized life style, industrialization and
improved socio-economic status, changed dietary pattern, altered microbial
exposure, stress, intestinal permeability, exposure to infections, exposure to
medications (antibiotics (especially during childhood), NSAIDs, hormonal
therapy) and appendectomy. There is a need to study the role of various
environmental factors influencing the disease.
Novelty: We are proposing a
population based epidemiological study to determine the disease burden and evaluate
IBD associated environmental factors in north Indian population. Though good
epidemiological studies are available from Western worldin relation to
environmental factors, the information available from India is inadequate
possibly due to lack of population based registries, limitation of access to
health care facilities, limited availability of diagnostic tests, and
infectious diseases confounding the diagnosis.
Objective: We proposed to: 1.
To estimate the prevalence of IBD in Punjab
2. To study and
compare the role of various environmental factors in the development of IBD
Methods: This would be a
questionnaire based population study, which will
include screening of around 50,000 individuals. A survey will be conducted in
the state of Punjab, India. Punjab is divided into three major geographical
areas, Doaba, Majha, and Malwa which contain a total of 23 districts. Trained
survey teams consisting of a doctor, a phlebotomist, and two field workers will
visit selected households and administer the survey questionnaire, after
obtaining informed consent and assent from children willing to participate. The
study questionnaire will be administered as a face-to-face interview and
inquire about socio-demographic data, medical history, lifestyle information,
environmental factors [place of residence, living conditions, hygiene
(including access to safe drinking water and toilet facilities), exposure to pets/farm
animals, exposure to infections, exposure to medications (antibiotics, NSAIDs,
hormonal therapy), etc.] and symptoms suggestive of IBD.
Those with prolonged diarrhoea (≥ 4 weeks) with or without rectal
bleeding will be considered as suspected cases. These suspected cases will be
subjected to faecal calprotectin. Confirmatory tests will include video sigmoidoscopy/colonoscopy, rectal
biopsy and/or CT enterography. In
addition, patients’ already diagnosed and receiving treatment for IBD,
encountered during the survey, will be reviewed.
Expected outcome: Environmental
influences exert important roles on the pathogenesis and natural history of
IBD. This study aims to provide key mechanistic insights into how environmental
and lifestyle influences may modify susceptibility to IBD.
Keywords
Inflammatory bowel disease, environmental factors,
dietary practices, colonoscopy, faecal calprotectin
Abbreviations
IBD: Inflammatory bowel
disease
NSAIDs: Non-steroidal
anti-inflammatory drugs
Objectives of
the Project (1500)
To estimate the
prevalence of IBD in Punjab
To study the role of various environmental factors in
the development of IBD
Expected output
and outcome of the proposal (1500)
1. To estimate the prevalence
of IBD (Ulcerative colitis and Crohn’s Disease) in Punjab (India).
2.To access
the role of environmental factors as a risk factor in the development of IBD. |