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

NCT06785922 | Enrolling By Invitation DMC

• 1 other identifier: Si 224/2024
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Microbiota; Helicobacter Pylori; CagA; Gastric Cancer

Keywords

Gastric microbiota; Helicobacter pylori; CagA; Gastric cancer

Outcome Measures

Primary Outcomes (1)

• The differences in gastric microbiota (Diversity index)

  Diversity index: Shannon index, Simpson index

  On the 1 day of EGD

Secondary Outcomes (3)

• Microbiota composition

  On the 1 day of EGD

• Endoscopic finding

  During the EGD

• Pathological finding

  Within 2 week after EGD

Study Arms (2)

CagA positive H.pylori

OTHER

CagA positive H.pylori

Procedure: Stomach biopsy for gastric microbiota

CagA negative H.pylori

OTHER

Procedure: Stomach biopsy for gastric microbiota

Interventions

Stomach biopsy for gastric microbiota PROCEDURE

Stomach biopsy for gastric microbiota testing (16S RNA sequencing)

CagA negative H.pylori; CagA positive H.pylori

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2025
• First Posted: January 21, 2025
• Study Start: January 12, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 21, 2025

Record last verified: 2025-01

Locations

TH (1)