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

M

Mahidol University

Status

Invitation-only

Conditions

Gastric Microbiota
Gastric Cancer
Helicobacter Pylori
CagA

Treatments

Procedure: Stomach biopsy for gastric microbiota

Study type

Interventional

Funder types

Other

Identifiers

NCT06785922
Si 224/2024

Details and patient eligibility

About

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.

Enrollment

64 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

CagA positive H.pylori
Other group
Description:
CagA positive H.pylori
Treatment:
Procedure: Stomach biopsy for gastric microbiota
CagA negative H.pylori
Other group
Treatment:
Procedure: Stomach biopsy for gastric microbiota

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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