| 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
                  
                        
           
           | 
        
        
      | 
    | 
    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.    |