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