Differences in Gastric Microbiota in Patients Who Were Infected Between CagA Positive and Negative Helicobacter Pylori

Not Applicable

• Conditions: Gastric Microbiota; Helicobacter Pylori; CagA; Gastric Cancer

• Registration Number: NCT06785922
• Lead Sponsor: Mahidol University

Brief Summary

The goal of this clinical trial is to study the differences in gastric microbiota (Diversity index) between patients who were infected with CagA-positive Helicobacter pylori and CagA-negative Helicobacter pylori. The main question it aims to answer are:

The effect of Helicobacter pylori typing (CagA status) on gastric microbiota, what is the different?

Patients indicated for EGD at Siriraj Endoscopic Center will undergo a Helicobacter pylori test (Rapid urease test) If the result is positive, a stomach biopsy for gastric microbiota testing and CagA antibody testing will be conducted. Then, the patients will be divided into two groups: CagA-positive Helicobacter pylori and CagA-negative Helicobacter pylori.

To compare the differences in gastric microbiota in terms of species and biodiversity, as well as endoscopic results, etc.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-01
• Study Start: 2025-01-12
• Study First Submitted: 2025-01-15
• Study First Submitted QC: 2025-01-20
• Last Update Submitted: 2025-01-20
• Study First Posted: 2025-01-21
• Last Update Posted: 2025-01-21
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

• Patients aged over 18 with an indication for EGD
• Helicobacter pylori infection (Rapid urease test positive)

Exclusion Criteria

• Severe comorbidities: poorly controlled DM, ESRD, decompensated cirrhosis, Malignancy
• BMI ≤ 23 kg/m2
• Receiving medications that affect the gastric microbiota include Antibiotics, probiotics, or bismuth within 4 weeks, PPI within 2 weeks, NSAIDs or Metformin within 2 weeks
• History of cholecystectomy or proximal small bowel surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The differences in gastric microbiota (Diversity index)	On the 1 day of EGD	Diversity index: Shannon index, Simpson index

Secondary Outcome Measures

Name	Time	Method
Microbiota composition	On the 1 day of EGD	Prevalence of microbiota species
Endoscopic finding	During the EGD	Endoscopic finding was described by investigators
Pathological finding	Within 2 week after EGD	Pathological finding was described by pathologist

Trial Locations

Locations (1)

Faculty of internal medicine siriraj hospital, Mahidol university; 🇹🇭 Bangkok Noi, Bangkok, Thailand