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CTRI Number  CTRI/2019/07/020404 [Registered on: 29/07/2019] Trial Registered Prospectively
Last Modified On: 15/11/2019
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to assess the prevalence of celiac disease in high risk group in Asia 
Scientific Title of Study   A pilot study to estimate prevalence of Celiac disease in high risk-group in Asia (Asian celiac disease Study) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Govind Makharia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenterology and Human Nutrition, Room no 3065, Teaching block, 3rd floor
All India institute of Medical Sciences Ansari Nagar, New Delhi-110029, India
South
DELHI
110029
India 
Phone  91-11-26546546  
Fax  91-11-26588091  
Email  govindmakharia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Govind Makharia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenterology and Human Nutrition, Room no 3065, Teaching block, 3rd floor
All India institute of Medical Sciences Ansari Nagar, New Delhi-110029, India

DELHI
110029
India 
Phone  91-11-26546546  
Fax  91-11-26588091  
Email  govindmakharia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Govind Makharia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Gastroenterology and Human Nutrition, Room no 3065, Teaching block, 3rd floor
All India institute of Medical Sciences Ansari Nagar, New Delhi-110029, India

DELHI
110029
India 
Phone  91-11-26546546  
Fax  91-11-26588091  
Email  govindmakharia@gmail.com  
 
Source of Monetary or Material Support  
Takeda Pharmaceutical Company Limited 1-1, Nihonbashi-Honcho 2-chome, Chu-ku, Tokyo, 103-8668, Japan 
 
Primary Sponsor  
Name  Takeda Pharmaceutical Company Limited 
Address  1-1, Nihonbashi-Honcho 2-chome, Chuo-Chu, Tokyo 103-8688, Japan 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Thermo Fischer Scientific  Thermo Fisher Scientific 168 Third Avenue Waltham, MA USA 02451 
 
Countries of Recruitment     China
India
Indonesia
Japan
Malaysia
Singapore
Thailand  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Govind Makharia  All India Institute of Medical Sciences  Department of Gastroenterology and Human Nutrition, Room no 3065, Teaching block, 3rd floor All India institute of Medical Sciences Ansari Nagar, New Delhi-110029, India
South
DELHI 
91-11-26546546

govindmakharia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
AIIMS Institute Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K598||Other specified functional intestinal disorders,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. 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
 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To estimate the sero-prevalence of Celiac disease in patients with functional gastrointestinal disease patients in Asia  12 months 
 
Secondary Outcome  
Outcome  TimePoints 
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 
 
Target Sample Size   Total Sample Size="6000"
Sample Size from India="1000" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/12/2019 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/12/2019 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Until The 1970s, celiac disease (CeD) was considered to be an uncommon disease except for in western Europe, the global epidemiology of CeD now continues to evolve with improvement in the diagnostic tests, simplification of the diagnostic criteria and increase in awareness about the disease. Celiac disease is now a global disease and 0.7% of the world population is estimated to have CeD. While there is a global burden of 37 million to 59 million patients, current studies estimate that in most populations, over 80% of people with CeD remain undiagnosed. The Asian region is currently at the crossroads of the frontier of knowledge and awareness of CeD. In many Asian nations, CeD is still considered to be either non-existent or very rare. A notable 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 vast majority of them remain undiagnosed. Initial reports from Malaysia, China, Japan and Singapore suggest the existence of CeD in these countries. A meta-analysis of studies published from Asia, suggest that 0.6% of Asians have CeD. Furthermore, a meta-analysis of the predisposing factors predicts a high probability of occurrence of CeD in fair numbers in China. There are no formal reports on CeD from Indonesia, Korea, Taiwan and many other nations in this region. It is thus appropriate that the medical community across Asia define the extent of the problem and get prepared to handle an impending epidemic of CeD.

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

 
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