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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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  
Type  Name  Details 
 
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.

 
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