Study to assess the prevalence of celiac disease in high risk group in Asia

Not yet recruiting

Conditions: Other specified functional intestinal disorders,

Registration Number: CTRI/2019/07/020404

Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 6000

Inclusion Criteria

Age 18-60 2.
Both genders 3.
Willing to participate 4.
Patients with Irritable Bowel Syndrome (IBS) and 5.
Functional Dyspepsia (FD) as per Rome IV criteria.

Exclusion Criteria

1. Previously diagnosed cases of celiac disease 2. Patients on Gluten free diet 3. Refusal to provide consent 4. Pregnant women 5. HIV positive patients 6. Chronic NSAID intake 7. Active smoking 8. Inflammatory bowel disease 9. Dysmorphic features and disproportionate short stature 10. Comorbid severe conditions.
pulmonary, renal, liver, cardiac, chronic illness and medication.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To estimate the sero-prevalence of Celiac disease in patients with functional gastrointestinal disease patients in Asia	12 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
South, DELHI, India
All India Institute of Medical Sciences
🇮🇳South, DELHI, India
Dr Govind Makharia
Principal investigator
11-26546546
govindmakharia@gmail.com