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Enrolling by Invitation

NCT Number: NCT06785922

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

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.

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Key information

Conditions

Gastric Microbiota CagA Digestive System Diseases Digestive System Neoplasms Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Helicobacter Pylori Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of internal medicine siriraj hospital, Mahidol university

Bangkok Noi, Bangkok, 10700, Thailand

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stomach biopsy for gastric microbiota

Procedure

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

Primary outcomes

  1. The differences in gastric microbiota (Diversity index)

    Time frame: On the 1 day of EGD

    Diversity index: Shannon index, Simpson index

Secondary outcomes

  1. Microbiota composition

    Time frame: On the 1 day of EGD

    Prevalence of microbiota species

  2. Endoscopic finding

    Time frame: During the EGD

    Endoscopic finding was described by investigators

  3. Pathological finding

    Time frame: Within 2 week after EGD

    Pathological finding was described by pathologist

Sponsors and collaborators

Lead sponsor

Mahidol University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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