Correlating patients symptoms and findings on upper gastrointestinal endoscopy with the presence of H. pylori infectionAdditional genetic testing of the sample for detection of H.pylori species

Not yet recruiting

• Conditions: Other gastritis,

• Registration Number: CTRI/2020/03/023785
• Lead Sponsor: Dr Janani Seshasayee

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

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2020-03-03
• Study Start: 2020-09-03

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 385

Inclusion Criteria

Patients undergoing UGI scopy, consenting for filling the questionnaire.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To help detect more cases of H.pylori based on UGI scopy mucosal findings	1 year 6 months
enabling earlier diagnosis and prompting stringent need for multiple gastric biopsies.	1 year 6 months

Secondary Outcome Measures

Name	Time	Method
To identify prevalence of H.pylori in patients on UGI scopy for	enhancing management techniques for eradication of H.pylori.

Trial Locations

Locations (1)

CHARAKA SCOPY ROOM; 🇮🇳 Udupi, KARNATAKA, India

CHARAKA SCOPY ROOM

🇮🇳Udupi, KARNATAKA, India

Dr Janani Seshasayee

Principal investigator

9962488858

janani111194@gmail.com