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CTRI Number  CTRI/2025/12/099966 [Registered on: 30/12/2025] Trial Registered Prospectively
Last Modified On: 26/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   Development of Disease Activity Index for Celiac Disease 
Scientific Title of Study   Derivation and Validation of a classification system for defining Response and Remission to Gluten-free diet in patients with Celiac Disease 
Trial Acronym  NIL 
Secondary IDs if Any    
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Govind K Makharia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room No. 3065 Department of Gastroenterology and Human Nutrition Teaching Block Ansari Nagar, Delhi

South
DELHI
110029
India 
Phone  9910678476  
Fax    
Email  govindmakharia@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Govind K Makharia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 3065 Department of Gastroenterology and Human Nutrition Teaching block Ansari Nagar, Delhi

South
DELHI
110029
India 
Phone  9910678476  
Fax    
Email  govindmakharia@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Govind K Makharia 
Designation  Professor 
Affiliation  All India Institute of Medical Sciences, New Delhi 
Address  Room 3065 Department of Gastroenterology and Human Nutrition Teaching block Ansari Nagar, Delhi

South
DELHI
110029
India 
Phone  9910678476  
Fax    
Email  govindmakharia@gmail.com  
 
Source of Monetary or Material Support  
University Grants Commission Bahadur Shah Zafar Marg, New Delhi - 110002  
 
Primary Sponsor  
Name  University Grants Commission  
Address  Bahadur Shah Zafar Marg, New Delhi - 110002 
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Govind K Makharia  All India Institute of Medical Sciences, New Delhi  Room No. 3065 Department of Gastroenterology and Human Nutrition Teaching Block Ansari Nagar, Delhi-110029
South
DELHI 
9910678476

govindmakharia@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institute Ethics Committee for Post graduate Research, All India Institute of Medical Sciences, New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K318||Other specified diseases of stomach and duodenum,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Patients with Celiac disease on a Gluten-free Diet
1. Patients with celiac disease as defined by positive Celiac Serology and proven by small intestinal mucosal biopsy: Diagnosis of CeD to be based on the combination of clinical manifestations, positive IgA anti-tTG antibody, and a deep duodenal biopsy demonstrating the presence of villous abnormalities of at least Marsh grade 2 (ICMR Guideline on Diagnosis and Management of Celiac Disease) [10]
2. Age: 18 to 60 years
3. Gender: Both male and female patients with CeD
 
 
ExclusionCriteria 
Details  1. Patients not willing to participate in the study
2. Patients with chronic illness (Cancer/Chronic Kidney Disease)
3. Pregnant or lactating mothers
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Disease Activity Index  Baseline, 3 months, 6 months, 12 months 
 
Secondary Outcome  
Outcome  TimePoints 
Response to Gluten-free diet score  6 months 1 year  
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   26/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Open to Recruitment 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [govindmakharia@gmail.com].

  6. For how long will this data be available start date provided 24-10-2027 and end date provided 01-10-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   We are developing a Disease Activity Index and a classification system for defining Response and Remission to Gluten-free diet in patients with Celiac Disease. 

A classification system for assessing the response to Gluten-free diet which is the only available treatment to Celiac Disease does not exist. The definition of remission is unclear, whether to look at clinical remission, serological remission or histological remission or a combination of all three; how much improvement in the patient can be called remission, how much improvement can we expect in the patient and after how much time of beginning of gluten-free diet should we expect remission. All these questions require consensus from experts in the field of celiac disease and should come through a systematic study. The monitoring and follow-up protocol of patients with Celiac Disease is not uniform globally and there are variations in the monitoring practices and therefore there is a need to standardise them as well.

Purpose

“The enemy of medical progress is hypothetical or speculative reasoning of physicians”. With the development of a classification system, the response of patient to gluten-free diet will be assessed using a standard, objective tool that forms its basis on the subjective reasoning of the physicians. This will lead to improvement in patient-care, by looking at the grey area, between Non-responsive Celiac Disease and Responsive Celiac Disease, and help to provide personalised care. The score will also provide a universal approach to assess response and remission in patients with Celiac Disease but also at the same time being precise enough for an individual patient. A classification system will also be useful after drug discovery during clinical trials to define response and remission and a measure of Disease Activity. The study will be one of the initial steps to form the basis of monitoring practices owing to its regular follow-up method and assessment of dynamics of recovery.

 
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