H. Pylori InfectionNCT05544396
Study on the Probiotics Regulating miRNA in H. Pylori-induced Wnt/β-catenin Gastric Carcinogenesis.
A study testing probiotic in people with H. Pylori Infection and Carcinogenesis, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
Background. H. pylori has recognized as a type 1 carcinogen for gastric adenocarcinoma. Although H. pylori eradication promises to reduce the risk of gastric cancer, the regression rate of intestinal metaplasia (IM) after eradication is unsatisfactory. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- H. Pylori Infection, Carcinogenesis
- What is being tested?
- probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 20 Mar 2024to 31 Jul 2030
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 20 years of age or older
- Have undergone gastroscopy
- First discovered H.pylori infection and intestinal metaplasia
Who cannot join
- Massive bleeding is life-threatening
- Gastric cancer
- Previous treatment for H.pylori
- Long-term use of non-steroidal anti-inflammatory drugs (eg, aspirin), and hydrogen ion pump inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Background. H. pylori has recognized as a type 1 carcinogen for gastric adenocarcinoma. Although H. pylori eradication promises to reduce the risk of gastric cancer, the regression rate of intestinal metaplasia (IM) after eradication is unsatisfactory. Therefore, to find the mechanism of IM persistent and a new strategy to improve IM regression are critical for reducing gastric cancer development. The canonical Wnt/beta-catenin signaling pathway upregulating cyclooxygenase-2 (COX-2) transcriptional activity involves gastric carcinogenesis after H. pylori infection. Investigators have established an in vitro model that H. pylori induces a cagA-dependent nuclear COX-2 expression in both GES-1 and AGS cells. MicroRNAs (miRNAs) are a class of widespread non-coding RNAs and have been shown to involve in the gastric carcinogenesis. Among these gastric cancer-related miRNA candidates, some were reported to interact with Wnt/β-catenin pathway. Clinically, H. pylori eradication plus celecoxib therapy results in about one-third cases being IM regression, which correlated to the nuclear β-catenin and COX-2 expression before treatment. Based on the probiotics ingestion can ameliorate H. pylori-induced inflammatory pathways, investigators hypothesis that H. pylori eradication with probiotics supplement may promote IM regression through regulating certain miRNAs and Wnt/β-catenin signaling. The aims of this 3-year grant will
- to establish the H. pylori induces the Wnt/beta-catenin and COX-2 signaling pathway in vitro.
- to investigate the effects and mechanisms of L. acidophilus and B. latis on H. pylori-induced Wnt/beta-catenin oncogenesis pathway.
- to study whether probiotics ingestion promote IM regression or ameliorate IM progression in H. pylori-infected patients after successful eradication therapy.
Read more
Materials and Methods. A H. pylori (HP238) isolate strain, GES-1, and AGS cells will be used for in vitro study. The protein levels of cell tests will measured by western blot. The differences of miRNAs expression between monk, cells infected with H. pylori, and cells pretreated with probiotics than infected by H. pylori will be analyzed by next generation sequencing method. H. pylori-infected patients with IM will be randomly allocated to receive probiotics or controls, the 2nd endoscopy will be arranged at the 12th month to evaluate the IM status.
Anticipated results. This study will to establish the H. pylori-induced Wnt/beta-catenin oncogenesis pathway in vitro. Furthermore, the effect and mechanism of probiotics inhibit the H. pylori-induced Wnt/beta-catenin signaling will be clarified. Finally, investigators will provide an evidence for the probiotics ingestion promote the rate of IM regression in patients after H. pylori eradication.
Read the detailed description
What are already know
- H. pylori-induced Wnt/beta-catenin cascades leads to gastric carcinogenesis.
- Nuclear beta-catenin and COX-2 expression correlated to the IM regression rate in human after H. pylori eradication.
- Administration of selective COX-2 inhibitos, celecoxib, results in partial IM regression in patients with long-term IM persistence after H. pylori eradication
- Certain miRNAs involve in gastric oncogenesis by targeting Wnt/beta-catenin signaling pathway.
What will be add
- The Wnt/beta-catenin oncogenesis induction is different between primary (GES-1), and cancer (AGS) gastric cells after H. pylori infection.
- Probiotics ameliorate or prevent H. pylori-induced gastric Wnt/beta-catenin/COX2 carcinogenesis signaling through regulating miRNAs.
- Probiotics administration improves regression rate in patients with CAG and IM after H. pylori successful eradication.
Diagram of clinical trial to evaluate probiotics ingestion improves H. pylori-related intestinal metaplasia (IM) in patients after eradication therapy
A.The dyspeptic patients receiving PES and biopsies will be continuously enrolled to find H. pylori infection and IM.
B.Investigators keep to allocate patients into probiotics-treatment and controls (each group 30 patients).
C.To compare the miRNA(s) serum levels in patients with IM regression and IM persistent by real-time PCR.
D.To analyze the significance of probiotics ingestion improves IM regression rate in the RTC.
- Conditions
- H. Pylori Infection, Carcinogenesis
- Being tested
- probiotic
- Keywords
- H. Pylori, Wnt/beta-catenin, miRNA, carcinogenesis
- Medical subject headings
- Carcinogenesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probioticOther
probiotic group give probiotics (2 packs per day) for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| probiotic group | Experimental | Routine eradicate treatment H. pylori, and probiotics (2 packs per day) for 6 months. Receives: Other: probiotic |
| control group | Placebo comparator | Only routine eradicate treatment H. pylori. Receives: Other: probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
The IM regression rate one year after H. pylori eradication
- pylori-infected participants (n=100) with IM received successful H. pylori eradication.
Group I (n=50) given oral probiotics 1 pack bid for 6 months, Group II did not treat.
The 2nd panendoscopy followed at one year later to evaluate IM status using Updated Sydney System Score.
Measured: Eligible participants allocated to treat or non-treat groups. The panendoscopy was performed one year later.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start20 Mar 2024
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for H. Pylori InfectionStudies of the same condition, open and under way.
- More trials run by National Cheng-Kung University HospitalThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yao-Jong Yang, National Cheng-Kung University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544396
- Sponsor's protocol ID
- A-BR-106-085
- Status last verified
- Nov 2024
- First submitted
- 6 Jul 2022
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The whole IPD will be shared after 2026.
Publications
Sheu BS, Tsai YC, Wu CT, Chang WL, Cheng HC, Yang HB. Long-term celecoxib can prevent the progression of persistent gastric intestinal metaplasia After H. pylori eradication. Helicobacter. 2013 Apr;18(2):117-23. doi: 10.1111/hel.12013. Epub 2012 Sep 26.
PubMed 23067366Hung KH, Wu JJ, Yang HB, Su LJ, Sheu BS. Host Wnt/beta-catenin pathway triggered by Helicobacter pylori correlates with regression of gastric intestinal metaplasia after H. pylori eradication. J Med Microbiol. 2009 May;58(Pt 5):567-576. doi: 10.1099/jmm.0.007310-0.
PubMed 19369517Yang YJ, Wu CT, Cheng HC, Chen WY, Tseng JT, Chang WL, Sheu BS. Probiotics ameliorate H. pylori-associated gastric beta-catenin and COX-2 carcinogenesis signaling by regulating miR-185. J Biomed Sci. 2025 Jun 3;32(1):55. doi: 10.1186/s12929-025-01149-3.
PubMed 40462044
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Probiotics Regulating miRNA in H. Pylori-induced Wnt/β-catenin Gastric Carcinogenesis.
- ClinicalTrials.gov ID
- NCT05544396
- Acronym / sponsor ID
- A-BR-106-085
- Conditions
- H. Pylori Infection, Carcinogenesis
- Keywords
- H. Pylori, Wnt/beta-catenin, miRNA, carcinogenesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Study start
- 20 Mar 2024 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2030 (estimated)
- First posted
- 16 Sep 2022 (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.
Background. H. pylori has recognized as a type 1 carcinogen for gastric adenocarcinoma. Although H. pylori eradication promises to reduce the risk of gastric cancer, the regression rate of intestinal metaplasia (IM) after eradication is unsatisfactory. Therefore, to find the mechanism of IM persistent and a new strategy to improve IM regression are critical for reducing gastric cancer development. The canonical Wnt/beta-catenin signaling pathway upregulating cyclooxygenase-2 (COX-2) transcriptional activity involves gastric carcinogenesis after H. pylori infection. Investigators have established an in vitro model that H. pylori induces a cagA-dependent nuclear COX-2 expression in both GES-1 and AGS cells. MicroRNAs (miRNAs) are a class of widespread non-coding RNAs and have been shown to involve in the gastric carcinogenesis. Among these gastric cancer-related miRNA candidates, some were reported to interact with Wnt/β-catenin pathway. Clinically, H. pylori eradication plus celecoxib therapy results in about one-third cases being IM regression, which correlated to the nuclear β-catenin and COX-2 expression before treatment. Based on the probiotics ingestion can ameliorate H. pylori-induced inflammatory pathways, investigators hypothesis that H. pylori eradication with probiotics supplement may promote IM regression through regulating certain miRNAs and Wnt/β-catenin signaling. The aims of this 3-year grant will
- to establish the H. pylori induces the Wnt/beta-catenin and COX-2 signaling pathway in vitro.
- to investigate the effects and mechanisms of L. acidophilus and B. latis on H. pylori-induced Wnt/beta-catenin oncogenesis pathway.
- to study whether probiotics ingestion promote IM regression or ameliorate IM progression in H. pylori-infected patients after successful eradication therapy.
Materials and Methods. A H. pylori (HP238) isolate strain, GES-1, and AGS cells will be used for in vitro study. The protein levels of cell tests will measured by western blot. The differences of miRNAs expression between monk, cells infected with H. pylori, and cells pretreated with probiotics than infected by H. pylori will be analyzed by next generation sequencing method. H. pylori-infected patients with IM will be randomly allocated to receive probiotics or controls, the 2nd endoscopy will be arranged at the 12th month to evaluate the IM status.
Anticipated results. This study will to establish the H. pylori-induced Wnt/beta-catenin oncogenesis pathway in vitro. Furthermore, the effect and mechanism of probiotics inhibit the H. pylori-induced Wnt/beta-catenin signaling will be clarified. Finally, investigators will provide an evidence for the probiotics ingestion promote the rate of IM regression in patients after H. pylori eradication.
Detailed description
What are already know
- H. pylori-induced Wnt/beta-catenin cascades leads to gastric carcinogenesis.
- Nuclear beta-catenin and COX-2 expression correlated to the IM regression rate in human after H. pylori eradication.
- Administration of selective COX-2 inhibitos, celecoxib, results in partial IM regression in patients with long-term IM persistence after H. pylori eradication
- Certain miRNAs involve in gastric oncogenesis by targeting Wnt/beta-catenin signaling pathway.
What will be add
- The Wnt/beta-catenin oncogenesis induction is different between primary (GES-1), and cancer (AGS) gastric cells after H. pylori infection.
- Probiotics ameliorate or prevent H. pylori-induced gastric Wnt/beta-catenin/COX2 carcinogenesis signaling through regulating miRNAs.
- Probiotics administration improves regression rate in patients with CAG and IM after H. pylori successful eradication.
Diagram of clinical trial to evaluate probiotics ingestion improves H. pylori-related intestinal metaplasia (IM) in patients after eradication therapy
A.The dyspeptic patients receiving PES and biopsies will be continuously enrolled to find H. pylori infection and IM.
B.Investigators keep to allocate patients into probiotics-treatment and controls (each group 30 patients).
C.To compare the miRNA(s) serum levels in patients with IM regression and IM persistent by real-time PCR.
D.To analyze the significance of probiotics ingestion improves IM regression rate in the RTC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic group | Experimental | Other: probioticRoutine eradicate treatment H. pylori, and probiotics (2 packs per day) for 6 months. |
| control group | Placebo comparator | Other: probioticOnly routine eradicate treatment H. pylori. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 20 years of age or older
- Have undergone gastroscopy
- First discovered H.pylori infection and intestinal metaplasia
Key exclusion criteria (4 listed)
- Massive bleeding is life-threatening
- Gastric cancer
- Previous treatment for H.pylori
- Long-term use of non-steroidal anti-inflammatory drugs (eg, aspirin), and hydrogen ion pump inhibitors.
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 |
|---|---|---|
| probioticprobiotic group give probiotics (2 packs per day) for 6 months. | Other | control group, probiotic group |
Primary outcome
The IM regression rate one year after H. pylori eradication
Time frame: Eligible participants allocated to treat or non-treat groups. The panendoscopy was performed one year later.
H. pylori-infected participants (n=100) with IM received successful H. pylori eradication. Group I (n=50) given oral probiotics 1 pack bid for 6 months, Group II did not treat. The 2nd panendoscopy followed at one year later to evaluate IM status using Updated Sydney System Score.
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 14 Nov 2024.
- Background: PubMed 23067366Sheu BS, Tsai YC, Wu CT, Chang WL, Cheng HC, Yang HB. Long-term celecoxib can prevent the progression of persistent gastric intestinal metaplasia After H. pylori eradication. Helicobacter. 2013 Apr;18(2):117-23. doi: 10.1111/hel.12013. Epub 2012 Sep 26.
- Background: PubMed 19369517Hung KH, Wu JJ, Yang HB, Su LJ, Sheu BS. Host Wnt/beta-catenin pathway triggered by Helicobacter pylori correlates with regression of gastric intestinal metaplasia after H. pylori eradication. J Med Microbiol. 2009 May;58(Pt 5):567-576. doi: 10.1099/jmm.0.007310-0.
- Derived from this study: PubMed 40462044Yang YJ, Wu CT, Cheng HC, Chen WY, Tseng JT, Chang WL, Sheu BS. Probiotics ameliorate H. pylori-associated gastric beta-catenin and COX-2 carcinogenesis signaling by regulating miR-185. J Biomed Sci. 2025 Jun 3;32(1):55. doi: 10.1186/s12929-025-01149-3.
- Individual participant dataSharing planned: No. The whole IPD will be shared after 2026.
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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. This study is not recruiting at the moment.
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 probiotic in people with H. Pylori Infection and Carcinogenesis, run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 14 Nov 2024. 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 Taiwan. 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. Some participants in this study may receive a placebo. 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 IM regression rate one year after H. pylori eradication (time frame: Eligible participants allocated to treat or non-treat groups. The panendoscopy was performed one year later.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05544396, which also lists 3 linked publications.
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 14 Nov 2024.