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

NCT ID: NCT06785922

Last Updated: 2025-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-12

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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Gastric Microbiota Helicobacter Pylori CagA Gastric Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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CagA positive H.pylori

CagA positive H.pylori

Group Type OTHER

Stomach biopsy for gastric microbiota

Intervention Type PROCEDURE

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

CagA negative H.pylori

Group Type OTHER

Stomach biopsy for gastric microbiota

Intervention Type PROCEDURE

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

Interventions

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Stomach biopsy for gastric microbiota

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, Thailand

Site Status

Countries

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Thailand

Other Identifiers

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Si 224/2024

Identifier Type: -

Identifier Source: org_study_id

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