H.Pylori Gastrointestinal DiseaseNCT05577572
Second Line Bismuth Containing Quadruple Therapy With Supplementary Probiotic
A study testing Probiotics packets in people with H.Pylori Gastrointestinal Disease, run by National Taiwan University Hospital at 4 sites in Taiwan.
Trial summary
This study is designed to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- H.Pylori Gastrointestinal Disease
- What is being tested?
- Probiotics packets
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 4 sitesTaiwan
- Study dates
- 29 Aug 2021to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients older than 20 years-old underwent documented non-Bismuth containing 1st line H. pylori eradication with failure defined by positive 13C-Urea Breath Test (13C-UBT) at least 6 weeks after completion of therapy is eligible to the study.
Who cannot join
- History of gastrectomy, surgery in the small intestine or colon
- History of gastric malignancy, including adenocarcinoma or lymphoma
- Allergic history, history of severe adverse effects or contraindication to antibiotics (Tetracycline, Metronidazole ), proton pump inhibitor, or probiotics
- Pregnant or lactating women
- Severe concurrent chronic or acute disease (e.g. renal failure, liver cirrhosis, or active malignancy)
- Concomitant use of clopidogrel or warfarin
Show all 9Show fewer
- Recent (<4 weeks) use of antibiotics, or recent (<4 weeks) probiotic use duration >2 weeks
- Not able to give consent on blinding or randomizatio
- Not able to give consent by his or herself
Trial locations and contacts
4 sites in 1 country.
Taiwan4 sites, 4 recruiting
- Recruiting
National Taiwan University Hospital Yunlin Branch
Douliu, 64041
Yu-Jen Fang, Doctor, +886-972-655374, toby851072@yahoo.com.tw
Yu-Jen Fang
- Not yet recruiting
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756
JHENG-YI WU, +886-988-358359, joywu@kmu.edu.tw
JHENG-YI WU
- Recruiting
National Taiwan University Hospital
Taipei, 100225
Jyh-Ming Liou, doctor, +886-972-651883, nneder34@gmail.com
Ming-Lun Han
- Recruiting
National Taiwan University Cancer Center
Taipei, 10672
Jyh-Ming Liou, Doctor
Jyh-Ming Liou, +886-972-651883, nneder34@gmail.com
About this study
Official title: The Effect of Supplementary Probiotic in the Dysbiosis of Gut Microbiota Caused by Second Line Bismuth Containing Quadruple Therapy in Helicobacter Pylori Eradication- A Multicentered, Randomized Double Blind Placebo-controlled Trial
This study is designed to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication
Read the detailed description
The role of Helicobacter pylori infection in the development of peptic ulcer disease and gastric cancer have been studied extensively. Eradication of H. pylori decreases the incidence of peptic ulcer and also gastric cancer. First line therapies for H. pylori eradication with PPI and antibiotic combinations considering local clarithromycin resistant rate reaching successful rates above 90%. Bismuth containing quadruple therapy (BQT), as a major choice of second line therapy, is widely prescribed but with considerable gastrointestinal side effects including diarrhea, nausea, vomiting, bloating and abdominal pain. Probiotics supplementation is defined as the adding of non-pathologic living microorgnisms. Numerous recent studies including meta-analyses and several randomized control trials revealed supplementary probiotics may improve the adverse effects and increase the successful rate of eradication therapy. Therefore, this study aim to assess the clinical impact of probiotics on Bismuth therapy and eradication of H. pylori.
It's a multicentered, randomized double blind placebo-controlled trial to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication. During the study, expected 200 patients failing in first-line Bismuth therapy would be enrolled in the trial. 200 patients are divided into two groups: one group receive probiotic for treatment period and the other group receive placebo. The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and probiotic (or placebo) is taken from day 1~56.
There are 5 visits for subjects to follow: day 0, day 10, day 56, 1 year and 3 years(optional). Esophagogastroduodenal scope for the pathology, H. pylori culture, susceptibility testing, genotypic resistance and virulence factors before D0. 13C-Urea breath tests are used to check Helicobacter pylori eradication on day 56, 1 year and 3 year. In addition to blood samples for general tests, stool samples would be collected on every visit to analyze gut microbiota.
- Conditions
- H.Pylori Gastrointestinal Disease
- Being tested
- Probiotics packets, Placebo packets
- Keywords
- supplementary pylori, Bismuth quadruple therapy, H. pylori eradication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotics packetsDietary supplement
The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and Probiotics packets is taken from day 1~56.
Placebo packetsDietary supplement
The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and Placebo packets is taken from day 1~56.
| Study group | Role | What they receive |
|---|---|---|
| Probiotics packets | Experimental | Probiotics contains 450 billion colony-forming units per packet. The compositions are maltose, lactic acid bacteria and bifidobacteria blend, cornstarch, silicon dioxide. Receives: Dietary Supplement: Probiotics packets |
| Placebo packets | Placebo comparator | The compositions are maltodextrin, silicon dioxide, sucralose Receives: Dietary Supplement: Placebo packets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Adverse events are collected
Measured: From Day 0 to Day 10.
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Adverse events are collected
Measured: From Day 0 to Day 56.
Secondary outcomes (20)
Eradication rate of second line BQT between two groups
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Measured: From Day 0 to Day 56.
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: Day 0.
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: Day 0.
Re-infection rate 1 year and 3 years after second line eradication therapy
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Measured: From Day 0 to Day 56.
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Measured: Day 0.
Eradication rate of second line BQT between two groups
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Measured: From Day 0 to 1 year.
Eradication rate of second line BQT between two groups
13C-Urea breath tests are performed to check the eradication of Helicobacter pylori between two groups
Measured: From Day 0 to 3 years.
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: Day 10.
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: Day 56.
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: 1 year.
Dynamic changes in the gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: 3 years.
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: Day 10.
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: Day 56 .
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: 1 year .
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Stool sample collection for gut microbiota analysis
Measured: 3 years.
Re-infection rate 1 year and 3 years after second line eradication therapy
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Measured: From Day 0 to 1 year.
Re-infection rate 1 year and 3 years after second line eradication therapy
13C-Urea breath tests are performed to check the Helicobacter pylori infection
Measured: From Day 0 to 3 years.
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Measured: Day 56.
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Measured: 1 year.
Changes in the parameters of metabolic syndrome between two groups
Blood samples are collected for glucose, insulin, HbA1c, and lipid profiles, liver function tests, renal function tests as well as CRP. Also, transabdominal sonography for fatty liver severity assessment would be performed.
Measured: 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start29 Aug 2021
- Primary completion29 Apr 2023 (estimated)
- Study completion29 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for H.Pylori Gastrointestinal DiseaseStudies of the same condition, open and under way.
- More trials run by National Taiwan 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 200 patients are divided into two groups: one group receive probiotic for treatment period and the other group receive placebo. The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1\~10 and probiotic (or placebo) is taken from day 1\~56.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ming-Lun Han, doctor, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577572
- Sponsor's protocol ID
- 201912191MIPC
- Status last verified
- Sep 2022
- First submitted
- 14 Jun 2021
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Supplementary Probiotic in the Dysbiosis of Gut Microbiota Caused by Second Line Bismuth Containing Quadruple Therapy in Helicobacter Pylori Eradication- A Multicentered, Randomized Double Blind Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05577572
- Acronym / sponsor ID
- 201912191MIPC
- Conditions
- H.Pylori Gastrointestinal Disease
- Keywords
- supplementary pylori, Bismuth quadruple therapy, H. pylori eradication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Aug 2021 (actual)
- Primary completion
- 29 Apr 2023 (estimated)
- Study completion
- 29 Apr 2025 (estimated)
- First posted
- 13 Oct 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.
This study is designed to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication
Detailed description
The role of Helicobacter pylori infection in the development of peptic ulcer disease and gastric cancer have been studied extensively. Eradication of H. pylori decreases the incidence of peptic ulcer and also gastric cancer. First line therapies for H. pylori eradication with PPI and antibiotic combinations considering local clarithromycin resistant rate reaching successful rates above 90%. Bismuth containing quadruple therapy (BQT), as a major choice of second line therapy, is widely prescribed but with considerable gastrointestinal side effects including diarrhea, nausea, vomiting, bloating and abdominal pain. Probiotics supplementation is defined as the adding of non-pathologic living microorgnisms. Numerous recent studies including meta-analyses and several randomized control trials revealed supplementary probiotics may improve the adverse effects and increase the successful rate of eradication therapy. Therefore, this study aim to assess the clinical impact of probiotics on Bismuth therapy and eradication of H. pylori.
It's a multicentered, randomized double blind placebo-controlled trial to evaluate the clinical outcome of second line Bismuth containing quadruple therapy with supplementary probiotic for Helicobacter pylori eradication. During the study, expected 200 patients failing in first-line Bismuth therapy would be enrolled in the trial. 200 patients are divided into two groups: one group receive probiotic for treatment period and the other group receive placebo. The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and probiotic (or placebo) is taken from day 1~56.
There are 5 visits for subjects to follow: day 0, day 10, day 56, 1 year and 3 years(optional). Esophagogastroduodenal scope for the pathology, H. pylori culture, susceptibility testing, genotypic resistance and virulence factors before D0. 13C-Urea breath tests are used to check Helicobacter pylori eradication on day 56, 1 year and 3 year. In addition to blood samples for general tests, stool samples would be collected on every visit to analyze gut microbiota.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 200 patients are divided into two groups: one group receive probiotic for treatment period and the other group receive placebo. The treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and probiotic (or placebo) is taken from day 1~56.
| Arm | Type | Receives |
|---|---|---|
| Probiotics packets | Experimental | Dietary Supplement: Probiotics packetsProbiotics contains 450 billion colony-forming units per packet. The compositions are maltose, lactic acid bacteria and bifidobacteria blend, cornstarch, silicon dioxide. |
| Placebo packets | Placebo comparator | Dietary Supplement: Placebo packetsThe compositions are maltodextrin, silicon dioxide, sucralose |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients older than 20 years-old underwent documented non-Bismuth containing 1st line H. pylori eradication with failure defined by positive 13C-Urea Breath Test (13C-UBT) at least 6 weeks after completion of therapy is eligible to the study.
Key exclusion criteria (9 listed)
- History of gastrectomy, surgery in the small intestine or colon
- History of gastric malignancy, including adenocarcinoma or lymphoma
- Allergic history, history of severe adverse effects or contraindication to antibiotics (Tetracycline, Metronidazole ), proton pump inhibitor, or probiotics
- Pregnant or lactating women
- Severe concurrent chronic or acute disease (e.g. renal failure, liver cirrhosis, or active malignancy)
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 |
|---|---|---|
| Probiotics packetsThe treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and Probiotics packets is taken from day 1~56. | Dietary supplement | Probiotics packets |
| Placebo packetsThe treatment period is designed for 56 days: Bismuth containing quadruple therapy is performed from day 1~10 and Placebo packets is taken from day 1~56. | Dietary supplement | Placebo packets |
Primary outcome
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Time frame: From Day 0 to Day 10.
Adverse events are collected
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses.
Time frame: From Day 0 to Day 56.
Adverse events are collected
20 secondary outcomes
Eradication rate of second line BQT between two groups
Time frame: From Day 0 to Day 56.
Dynamic changes in the gut microbiota between two groups
Time frame: Day 0.
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Time frame: Day 0.
Re-infection rate 1 year and 3 years after second line eradication therapy
Time frame: From Day 0 to Day 56.
Changes in the parameters of metabolic syndrome between two groups
Time frame: Day 0.
Eradication rate of second line BQT between two groups
Time frame: From Day 0 to 1 year.
Eradication rate of second line BQT between two groups
Time frame: From Day 0 to 3 years.
Dynamic changes in the gut microbiota between two groups
Time frame: Day 10.
Dynamic changes in the gut microbiota between two groups
Time frame: Day 56.
Dynamic changes in the gut microbiota between two groups
Time frame: 1 year.
Dynamic changes in the gut microbiota between two groups
Time frame: 3 years.
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Time frame: Day 10.
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Time frame: Day 56 .
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Time frame: 1 year .
Dynamic changes in the metabolic pathway of gut microbiota between two groups
Time frame: 3 years.
Re-infection rate 1 year and 3 years after second line eradication therapy
Time frame: From Day 0 to 1 year.
Re-infection rate 1 year and 3 years after second line eradication therapy
Time frame: From Day 0 to 3 years.
Changes in the parameters of metabolic syndrome between two groups
Time frame: Day 56.
Changes in the parameters of metabolic syndrome between two groups
Time frame: 1 year.
Changes in the parameters of metabolic syndrome between two groups
Time frame: 3 years.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Ming-Lun Han, doctor principal investigator
National Taiwan University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotics packets in people with H.Pylori Gastrointestinal Disease, run by National Taiwan University Hospital at 4 sites 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 1 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 21 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jyh-Ming Liou, doctor (+886-972-651883, nneder34@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the incidence of adverse effects after second line BQT between probiotic group (L) and placebo group (P) according to intentional to treat (ITT) and per-protocol (PP) analyses. (time frame: From Day 0 to Day 10.). The study lists 2 primary outcomes in all. 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 Oct 2022.