| 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
|
|
|
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
|
|
|
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
|
|
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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
- 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).
- 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
- 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.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [govindmakharia@gmail.com].
- 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.
- 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. |