跳至主要内容
临床试验/CTRI/2022/05/042815
CTRI/2022/05/042815招募中不适用

A population based epidemiological study of inflammatory bowel disease in Punjab India

Dayanand Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2022年1月6日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
500
试验地点
1
主要终点
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.

研究概览

简要总结

Background: The incidence/prevalencerates of Inflammatory Bowel Disease (IBD) are rising in Asian countries withIndia probably topping the list. Improved physician awareness and betterdiagnostic modalities lone are not likely to account fully for this rise.Clinical and experimental evidence supports an association between IBD and alarge number of seemingly unrelated environmental factors, which includesmoking, improved sanitation, westernized life style, industrialization andimproved socio-economic status, changed dietary pattern, altered microbialexposure, stress, intestinal permeability, exposure to infections, exposure tomedications (antibiotics (especially during childhood), NSAIDs, hormonaltherapy) and appendectomy. There is a need to study the role of variousenvironmental factors influencing the disease.

Novelty: We are proposing apopulation based epidemiological study to determine the disease burden and evaluateIBD associated environmental factors in north Indian population. Though goodepidemiological studies are available from Western worldin relation toenvironmental factors, the information available from India is inadequatepossibly due to lack of population based registries, limitation of access tohealth care facilities, limited availability of diagnostic tests, andinfectious diseases confounding the diagnosis.

Objective: We proposed to: 1.To estimate the prevalence of IBD in Punjab

  1. To study andcompare the role of various environmental factors in the development of IBD

Methods: This would be aquestionnaire based population study, which willinclude screening of around 50,000 individuals. A survey will be conducted inthe state of Punjab, India. Punjab is divided into three major geographicalareas, Doaba, Majha, and Malwa which contain a total of 23 districts. Trainedsurvey teams consisting of a doctor, a phlebotomist, and two field workers willvisit selected households and administer the survey questionnaire, afterobtaining informed consent and assent from children willing to participate. Thestudy questionnaire will be administered as a face-to-face interview andinquire 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/farmanimals, 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 rectalbleeding will be considered as suspected cases. These suspected cases will besubjected to faecal calprotectin. Confirmatory tests will include video sigmoidoscopy/colonoscopy, rectalbiopsy and/or CT enterography. Inaddition, patients’ already diagnosed and receiving treatment for IBD,encountered during the survey, will be reviewed.

Expected outcome: Environmentalinfluences exert important roles on the pathogenesis and natural history ofIBD. This study aims to provide key mechanistic insights into how environmentaland lifestyle influences may modify susceptibility to IBD.

Keywords

Inflammatory bowel disease, environmental factors,dietary practices, colonoscopy, faecal calprotectin

 Abbreviations

IBD: Inflammatory boweldisease

NSAIDs: Non-steroidalanti-inflammatory drugs

 Objectives ofthe Project (1500)

To estimate theprevalence of IBD in Punjab

To study the role of various environmental factors inthe development of IBD

Expected outputand outcome of the proposal (1500)

  1. To estimate the prevalenceof IBD (Ulcerative colitis and Crohn’s Disease) in Punjab (India).

2.To accessthe role of environmental factors as a risk factor in the development of IBD.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Month(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Any individual with chronic diarrhea (more than 4 weeks) with/ without rectal bleeding.

排除标准

  • Individuals with normal stool frequency.

结局指标

主要结局

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.

时间窗: 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

次要结局

  • 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.)

研究者

发起方
Dayanand Medical College and Hospital
申办方类型
Private medical college

研究点 (1)

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