Gastric MicrobiotaNCT06785922
Differences in Gastric Microbiota in Patients Who Were Infected Between CagA Positive and Negative Helicobacter Pylori
A study testing Stomach biopsy for gastric microbiota in people with Gastric Microbiota and Helicobacter Pylori, run by Mahidol University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Microbiota, Helicobacter Pylori, CagA
- What is being tested?
- Stomach biopsy for gastric microbiota
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteThailand
- Study dates
- 12 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged over 18 with an indication for EGD
- Helicobacter pylori infection (Rapid urease test positive)
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site
Faculty of internal medicine siriraj hospital, Mahidol university
Bangkok Noi, Bangkok, 10700
About this study
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?
Read more
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
- Being tested
- Stomach biopsy for gastric microbiota
- Keywords
- Gastric microbiota, Helicobacter pylori, CagA, Gastric cancer
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stomach biopsy for gastric microbiotaProcedure or surgery
Stomach biopsy for gastric microbiota testing (16S RNA sequencing)
| Study group | Role | What they receive |
|---|---|---|
| CagA positive H.pylori | Other | CagA positive H.pylori Receives: Procedure: Stomach biopsy for gastric microbiota |
| CagA negative H.pylori | Other | Not described Receives: Procedure: Stomach biopsy for gastric microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
The differences in gastric microbiota (Diversity index)
Diversity index: Shannon index, Simpson index
Measured: On the 1 day of EGD
Secondary outcomes (3)
Microbiota composition
Prevalence of microbiota species
Measured: On the 1 day of EGD
Endoscopic finding
Endoscopic finding was described by investigators
Measured: During the EGD
Pathological finding
Pathological finding was described by pathologist
Measured: Within 2 week after EGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start12 Jan 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric MicrobiotaStudies of the same condition, open and under way.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785922
- Sponsor's protocol ID
- Si 224/2024
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Differences in Gastric Microbiota in Patients Who Were Infected Between CagA Positive and Negative Helicobacter Pylori
- ClinicalTrials.gov ID
- NCT06785922
- Acronym / sponsor ID
- Si 224/2024
- Conditions
- Gastric Microbiota, Helicobacter Pylori, CagA, Gastric Cancer
- Keywords
- Gastric microbiota, Helicobacter pylori, CagA, Gastric cancer
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 12 Jan 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CagA positive H.pylori | Other | Procedure: Stomach biopsy for gastric microbiotaCagA positive H.pylori |
| CagA negative H.pylori | Other | Procedure: Stomach biopsy for gastric microbiota |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged over 18 with an indication for EGD
- Helicobacter pylori infection (Rapid urease test positive)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stomach biopsy for gastric microbiotaStomach biopsy for gastric microbiota testing (16S RNA sequencing) | Procedure or surgery | CagA negative H.pylori, CagA positive H.pylori |
Primary outcome
The differences in gastric microbiota (Diversity index)
Time frame: On the 1 day of EGD
Diversity index: Shannon index, Simpson index
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stomach biopsy for gastric microbiota in people with Gastric Microbiota and Helicobacter Pylori, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The differences in gastric microbiota (Diversity index) (time frame: On the 1 day of EGD). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2025.