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Enrolling by invitation NCT06785922

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

No phase Interventional Gastric Microbiota Helicobacter Pylori CagA Gastric Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Stomach biopsy for gastric microbiota.
Who it may be relevant to
Registry conditions: Gastric Microbiota, Helicobacter Pylori, CagA, Gastric Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Thailand
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

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

Primary outcome measures

  • The differences in gastric microbiota (Diversity index) [Time frame: On the 1 day of EGD]
Secondary outcome measures (3)
  • Microbiota composition [Time frame: On the 1 day of EGD]
  • Endoscopic finding [Time frame: During the EGD]
  • Pathological finding [Time frame: Within 2 week after EGD]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Basic science

Study locations

Thailand · 1 center
  • Faculty of internal medicine siriraj hospital, Mahidol university — Bangkok Noi

Identifiers

NCT: NCT06785922 · Si 224/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗