跳至主要内容
临床试验/CTRI/2020/08/027486
CTRI/2020/08/027486招募中不适用

Clinical spectrum of Inflammatory Bowel Disease in tertiary care centre in India

Dayanand Medical College and Hospital Ludhiana1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2020年1月9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
To study the clinical spectrum of patients with Inflammatory Bowel Disease in a tertiary care hospital in north India.

研究概览

简要总结

India appears to be on the epidemiological crossroadswhere infectious diseases as well as diseases hitherto considered to bediseases of the Western world are both being witnessed. Incidence andprevalence of IBD is increasing. The clinical spectrum of IBD in India islikely to be different from west because of differences in genetic andenvironmental influences. This has been partly looked into by a country-widesurvey of IBD from India. IBD in the West is characterized by a bimodal agedistribution with peaks at age groups 20–39 and 60–79 years. However the meanage at diagnosis of UC and CD was 38.5 and 35.9 years, respectively, in Indiaand is not associated with a second peak. Similarly gender distribution,disease location and behavior in India are expected to be distinct from west.The long-term disease course of Indian IBD patients including need forimmunosuppressives, biologics, surgical interventions and rates ofcomplications including colorectal carcinoma needs to be studied in detail.Malnutrition is a major complication of inflammatory bowel disease (IBD). Themain determinants of malnutrition in IBD include poor oral intake,malabsorption, chronically stimulated inflammatory cascade, gastrointestinalnutrient loss and increased energy expenditure. IBD can also alter thehomeostasis of muscles, bones, and fat leading to sarcopenia (defined as depletionin lean muscle mass coupled with a loss of muscle strength) and dysregulated body composition. Leanmass deficits have been associated with demonstrable morbidity, mortality, andreduced quality of life. Sarcopeniais common in patients with IBD and such patients have higher rates of bothsurgical interventions and postoperative complications. Other particularconcerns in IBD patients are that many of the patients are young, have activeinflammation, may be profoundly malnourished and are immunosuppressed. Despitethe risks and potential sequelae of low lean muscle mass and sarcopenia in IBD,there is a lack of high-quality data. A correct assessment of muscle mass andstrength as well as nutritional status that provides quantitative andqualitative evaluations is important and timely recognition ofsarcopenia/malnutrition may help in planning adequate and customizednutritional regimens. The presentation and spectrum of IBD has also changed inlast two decades.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Day(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients with Inflammatory Bowel Disease Patient’s demonstration of understanding of study requirements and treatment procedures, willingness to comply with all protocol-required evaluations.

排除标准

  • Pregnant/lactating female History or other evidence of severe illness or any other conditions that would make the patient, in the opinion of the investigator, unsuitable for the study (such as poorly controlled psychiatric disease, HIV, significant co-morbidities like advanced coronary artery disease, etc.).

结局指标

主要结局

To study the clinical spectrum of patients with Inflammatory Bowel Disease in a tertiary care hospital in north India.

时间窗: 1 year, 2 years, 5 years

次要结局

  • To study the clinical profile of patients with IBD presenting at different ages (17 years, 17-60 years and 60 years)(To study the requirement, use and response to immunosuppressants and biologics)

研究者

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

研究点 (1)

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