| CTRI Number |
CTRI/2024/08/072256 [Registered on: 09/08/2024] Trial Registered Prospectively |
| Last Modified On: |
09/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Diagnostic |
| Study Design |
Other |
|
Public Title of Study
|
Utility of testing Gluten immunogenic peptide levels in urine for checking compliance to diet in children with celiac disease. |
|
Scientific Title of Study
|
Urinary Gluten Immunogenic Peptide as a biomarker for monitoring adherence to diet in children with Celiac disease |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shreya Gupta |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics Maulana Azad Medical College and Lok Nayak Hospital Delhi 110002
Central
DELHI
110002
India |
| Phone |
9716861322 |
| Fax |
|
| Email |
shreya0298@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Seema Kapoor |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics Maulana Azad Medical College and Lok Nayak Hospital Delhi 110002
Central
DELHI
110002
India |
| Phone |
9868846606 |
| Fax |
|
| Email |
drseemakapoor@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Seema Kapoor |
| Designation |
Director Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Department of Pediatrics Maulana Azad Medical College and Lok Nayak Hospital Delhi 110002
Central
DELHI
110002
India |
| Phone |
9868846606 |
| Fax |
|
| Email |
drseemakapoor@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College and associated Lok Nayak Hospital, Central Delhi, Delhi 110002, India |
|
|
Primary Sponsor
|
| Name |
Dr Shreya Gupta |
| Address |
Department of Pediatrics, Maulana Azad Medical College and Lok Nayak Hospital |
| Type of Sponsor |
Other [self] |
|
|
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 Shreya Gupta |
Maulana Azad Medical College |
Department of Pediatrics Maulana Azad Medical College and Lok Nayak Hospital Delhi 110002
Central
DELHI |
9716861322
shreya0298@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Maulana Azad Medical Colleged |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Gluten free diet |
Testing levels of Urinary Gluten Immunogenic Peptide before and after initiating Gluten Free Diet in children diagnosed with Celiac disease. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children newly diagnosed with Celiac disease between 1-12 years age, presenting to the Department of Pediatrics. Diagnosis of CD will be made as per ESPGHAN 2020 criteria. |
|
| ExclusionCriteria |
| Details |
1.Patients with known chronic inflammatory bowel disease 2.Patients with a history of necrotizing enterocolitis and known short bowel syndrome 3.Patients with known chronic kidney disease
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in the urinary GIP levels from baseline after institution of gluten free diet |
At 1 week and at 1 month of starting gluten free diet |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association between Urinary GIP levels and anti tTG-IgA levels after 1 month of gluten free diet |
At 1 month of gluten free diet |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/08/2024 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
This is short term longitudinal study to evaluate use of urinary Gluten Immunogenic Peptide as a biomarker for monitoring adherence to gluten free diet in children with celiac disease conducted in department of pediatrics, Maulana Azad Medical college and Lok Nayak hospital. Children newly diagnosed with Celiac disease between 1-12 years age, presenting to the Department of Pediatrics will be enrolled and change in levels of
Urinary Gluten Immunogenic Peptide at 7 days and at 1 month of initiation of
Gluten-Free Diet will be analysed. The association of Urinary GIP levels and anti
tTG-IgA levels at baseline and after 1 month of GFD will also be assessed. The proposed sample size is of 30 patients. The aim is to evaluate if urinary Gluten immunogenic peptide levels can assess compliance to Gluten free diet.
|