| CTRI Number |
CTRI/2024/09/073823 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
05/09/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
TO assess the presence of allergic reaction to esophagus. |
|
Scientific Title of Study
|
Eosinophilic esophagitis-Indian scenario. |
| 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 Ganesh Bhat |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9900791615 |
| Fax |
|
| Email |
bhat.ganesh@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ganesh Bhat |
| Designation |
Professor and Head |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9900791615 |
| Fax |
|
| Email |
bhat.ganesh@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Anand Kumar R |
| Designation |
DM Resident |
| Affiliation |
Manipal Academy of Higher Education |
| Address |
Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India |
| Phone |
9740461517 |
| Fax |
|
| Email |
dranandkumar119@gmail.com |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Karnataka 576104 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NA |
| Type of Sponsor |
Other [NIL] |
|
|
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 Anand Kumar R |
Kasturba Medical College |
New OPD, 4th Floor, Department of Gastroenterology and Hepatology, Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal
Udupi
KARNATAKA |
9740461517
dranandkumar119@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K200||Eosinophilic esophagitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NA |
NA |
| Comparator Agent |
NA |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All patients above 18 years of age.
Symptoms suggestive of eosinophilic esophagitis like Heartburn, chronic reflux, dysphagia, food impaction and esophageal chest pain.
Any endoscopic evidence of eosinophilic esophagitis which include linear furrows, pinpoint exudates, feline rings, stricture, fixed rings, or esophagitis. |
|
| ExclusionCriteria |
| Details |
Cardio-respiratory, renal comorbidities precluding diagnostic endoscopy.
Patients with history of drug-induced esophagitis.
Crohn’s disease
Esophageal malignancy
Intake of PPI within last 4Â weeks. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the prevalence of eosinophilic esophagitis using aa standardized biopsy
protocol. |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To see for prevalence of eosinophilic esophagitis in GERD, Predictive factors for
eosinophilic esophagitis like atopy. |
6 months |
|
|
Target Sample Size
|
Total Sample Size="101"
Sample Size from India="101"
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)
|
20/09/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
After obtaining written informed consent and checking for exclusion criteria, patients with symptoms suggestive of GERD or esophageal dysfunction will be recruited for endoscopy. Information regarding relevant history, physical examination, demographic and laboratory parameters will be entered in a preformatted data sheet. All patients will undergo upper endoscopy. 4 biopsies from each quadrant will be taken 14cms and 4cms above the esophagogastric junctions regardless of macroscopic appearance using standard biopsy forceps. Biopsies will be stored in 10% formalin for pathological examination. The average eosinophil count in high power magnification will be taken for diagnosis. |