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临床试验/CTRI/2019/07/020404
CTRI/2019/07/020404尚未招募不适用

A pilot study to estimate prevalence of Celiac disease in high risk-group in Asia (Asian celiac disease Study)

Takeda Pharmaceutical Company Limited1 个研究点 分布在 1 个国家目标入组 6,000 人开始时间: 2019年1月12日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
6,000
试验地点
1
主要终点
To estimate the sero-prevalence of Celiac disease in patients with functional gastrointestinal disease patients in Asia

研究概览

简要总结

Until The 1970s, celiac disease (CeD) was considered to be an uncommon disease except forin western Europe, the global epidemiology of CeD now continues toevolve with improvement in the diagnostic tests, simplification of thediagnostic criteria and increase in awareness about the disease. Celiac disease is now a global disease and 0.7% of the worldpopulation is estimated to have CeD. While thereis a global burden of 37 million to 59 million patients, current studies estimatethat in most populations, over 80% of people with CeD remain undiagnosed. The Asian region is currently at the crossroads of the frontierof knowledge and awareness of CeD. In many Asian nations**,** CeD is stillconsidered to be either non-existent or very rare. Anotable exception is India, where CeD has been well recognized. In a pan-India population-based study, including 23,000 subjects,we have shown that about 6-8 million Indians have celiac disease and a vastmajority of them remain undiagnosed. Initial reports from Malaysia, China,Japan and Singapore suggest the existence of CeD in these countries. Ameta-analysis of studies published from Asia, suggest that 0.6% of Asians haveCeD. Furthermore, a meta-analysis of the predisposing factors predicts a highprobability of occurrence of CeD in fair numbers in China. There are no formal reports on CeD from Indonesia, Korea, Taiwanand many other nations in this region. It is thusappropriate that the medical community across Asia define the extent of the problem andget prepared to handle an impending epidemic of CeD.

We, therefore, propose a pilot study to estimate the prevalenceof CeD in high-risk group patients in certain Asian countries.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Age 18-60
  • Both genders
  • Willing to participate
  • Patients with Irritable Bowel Syndrome (IBS) and
  • Functional Dyspepsia (FD) as per Rome IV criteria.

排除标准

  • Previously diagnosed cases of celiac disease
  • Patients on Gluten free diet
  • Refusal to provide consent
  • Pregnant women
  • HIV positive patients
  • Chronic NSAID intake
  • Active smoking
  • Inflammatory bowel disease
  • Dysmorphic features and disproportionate short stature
  • Comorbid severe conditions.
  • pulmonary, renal, liver, cardiac, chronic illness and medication.

结局指标

主要结局

To estimate the sero-prevalence of Celiac disease in patients with functional gastrointestinal disease patients in Asia

时间窗: 12 months

次要结局

  • Prevalence of Celiac disease in patients with functional gastrointestinal diseases in Asian countries (anti-tTG Ab positive and either one of the following: a positive IgA anti-DGP Ab or demonstration of villous atrophy on duodenal biopsies)(12 months)

研究者

申办方类型
Pharmaceutical industry-Global

研究点 (1)

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