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CTRI Number  CTRI/2020/03/023785 [Registered on: 05/03/2020] Trial Registered Prospectively
Last Modified On: 03/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Correlating patients symptoms and findings on upper gastrointestinal endoscopy with the presence of H. pylori infection Additional genetic testing of the sample for detection of H.pylori species  
Scientific Title of Study   Correlation of patient symptomatology and gastric mucosal findings on upper gastrointestinal scopy with detection of helicobacter pylori on histopathological examination and genotyping of the helicobacter pylori species. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Janani Seshasayee 
Designation  Junior resident 
Affiliation  Kasturba medical college and hospital (MAHE) 
Address  Department of General Surgery Kasturba medical college and hospital (MAHE)

Udupi
KARNATAKA
576104
India 
Phone  9962488858  
Fax    
Email  janani111194@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Veena L Karanth 
Designation  Professor 
Affiliation  Kasturba medical college and hospital (MAHE) 
Address  Department of General Surgery Kasturba medical college and hospital (MAHE)

Udupi
KARNATAKA
576104
India 
Phone  9845417715  
Fax    
Email  karanthkvl@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Janani Seshasayee 
Designation  Junior resident 
Affiliation  Kasturba medical college and hospital (MAHE) 
Address  Department of General Surgery Kasturba medical college and hospital (MAHE)

Udupi
KARNATAKA
576104
India 
Phone  9962488858  
Fax    
Email  janani111194@gmail.com  
 
Source of Monetary or Material Support  
Department of General surgery, Kasturba medical college and hospital(MAHE), Manipal 576104, Karnataka  
 
Primary Sponsor  
Name  Dr Janani Seshasayee  
Address  Department of General Surgery Kasturba medical college and hospital (MAHE) 
Type of Sponsor  Other [SELF] 
 
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 Janani Seshasayee  CHARAKA SCOPY ROOM   BALLIGA BLOCK, 4TH FLOOR KASTURBA MEDICAL COLLEGE AND HOSPITAL (MAHE) MANIPAL 576104 KARNATAKA
Udupi
KARNATAKA 		 9962488858

janani111194@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K296||Other gastritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Patients undergoing UGI scopy, consenting for filling the questionnaire 
 
ExclusionCriteria 
Details   
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To help detect more cases of H.pylori based on UGI scopy mucosal findings
enabling earlier diagnosis and prompting stringent need for multiple gastric biopsies.
 		 1 year 6 months  
 
Secondary Outcome  
Outcome  TimePoints 
To identify prevalence of H.pylori in patients on UGI scopy for
enhancing management techniques for eradication of H.pylori.
To help in recording the risk factors
To provide a diagnostic tool for the detection of infection as well as guidance for treatment decisions.   
Genotyping of H.pylori prevalence in our population 		 1 year 6 months 
 
Target Sample Size   Total Sample Size="385"
Sample Size from India="385" 
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)   09/03/2020 
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="7"
Days="15" 
Recruitment Status of Trial (Global)   Not Applicable 
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  
This is a prospective observational study titled correlation of patient symptomatology and gastric mucosal findings on upper gastrointestinal scopy
with detection of H.Pylori on histopathological examination  and genotyping of the H.pylori species.

The prime objectives of this study include the following:
1. To identify the gastric mucosal findings on endoscopy associated with H.pylori positive biopsy specimens
2. To study the correlation of H.pylori associated gastritis in patients with upper GI symptoms.
3. To identify the risk factors for H.pylori positivity in patients with upper GI symptoms.
4. To study the genotypes of H.pylori prevalent in our population

The procedure of the study is as follows:
1. Consent is taken before recruitment of patient. During endoscopy, left over biopsy samples will be taken, will be stored in Bouin’s fluid and sent for genomic study. The procedure may take an additional 5-10 minutes. There will be no benefits or risks to the patient.
2. Pre determined questionnaire is administered to the patient.
3. Photographs are taken as per the proforma for mucosal patterns in addition to those taken during a routine UGI scopy procedure.
4. Histopathologic report is retrieved for analysis.
5. Method for Genetic study: An endoscopy-based biopsy and polymerase chain reaction (PCR) testing on gastric biopsies to diagnose the bacterium in 20 samples. DNA would be isolated from
the tissue samples nested PCR would be performed with H pylori specific sequence of 16s ribosomal RNA gene for detection and then confirmed with PCR for urease gene (ureA) specific
to H pylori. Conventional PCRs will be performed for determination of the virulence genes vacA and cagA PAI for samples positive for H. pylori-specific 16s and ureA genes, using primer designed for them
6. Longterm studies: If feasible, 385 samples will be collected for DNA/and RNA isolation for future validation/estimation of bacterial loads and occurrence of different virulence factors and
mutations associated with resistance to antimicrobial agents. Host DNA could be analysed for factors predisposing to susceptibility to infection. Phylogenetic analysis would also be
performed after DNA sequencing of the 16s ribosomal RNA gene segments from the H. pylori strains, also using sequences available in the public domain with NCBI-BLAST server and Clustal W program.

The expected outcome measures for the study include the following:
ï‚· The study will help to detect more cases of H.pylori based on UGI scopy mucosal findings enabling earlier diagnosis and prompting a stringent need for multiple gastric biopsies.
ï‚· The study will identify the prevalence of H.pylori in patients  on UGI scopy providing data on enhancing management techniques for eradication of H.pylori.
ï‚· The questionnaire will also help in recording the risk factors and tabulate the data 
ï‚· The immediate outcome is expected to provide a robust diagnostic tool for the detection of infection as well as guidance for treatment decisions.   
ï‚· Genotyping of H.pylori prevalence in our population
 
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