Helicobacter Pylori InfectionPhase 4NCT03722433
Probiotics in the Reduction of Adverse Effects and Dysbiosis of H. Pylori Eradication
A Phase 4 study testing Vigiis 101-LAB and sequential therapy in people with Helicobacter Pylori Infection, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
The investigators aimed to assess the effect of probiotic supplementation with Vigiis 101-LAB during H. pylori eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Vigiis 101-LAB and sequential therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Aug 2018to 31 Jul 2020
- Phase
- Phase 4
- 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
- Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment.
Who cannot join
- children and teenagers aged less than 20 years
- history of gastrectomy
- gastric malignancy, including adenocarcinoma and lymphoma
- previous allergic reaction to antibiotics (amoxicillin, metronidazole, clarithromycin, probiotics) and PPI (esomeprazole)
- contraindication to treatment drugs
- pregnant or lactating women
Show all 9Show fewer
- severe concurrent disease
- concomitant use of clopidogrel
- unwilling to accept random assignment of subjects
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Jyh-Ming Liou
Taipei, Taiwan, 10002
Jyh-Ming Liou, jyhmingliou@gmail.com
About this study
Official title: The Efficacy of Probiotic Supplementation in the Reduction of Adverse Effects and Dysbiosis of Helicobacter Pylori Eradication Therapy - A Double Blind, Multi-center Randomized, Placebo Controlled Trial
The investigators aimed to assess the effect of probiotic supplementation with Vigiis 101-LAB during H. pylori eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Read the detailed description
Backgroud: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and the recurrence rate of peptic ulcer disease. However, the adverse effects, such as diarrhea and abdominal pain occurred in about 20-30% of patient during eradication therapies for H. pylori. Dysbiosis of the gut microbiota might contribute to the adverse effects.
Aims: Therefore, the investigators aimed to assess the efficacy of probiotic supplementation during the eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Methods:
This will be a double-blind, placebo controlled, multi-center randomized trial. 200 patients with H. pylori infection naïve to eradication therapy will be enrolled.
Before First Line Treatment: Any two positive of CLO test, histology, serology and culture or a positive UBT will be considered as H. pylori infected.
After First Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after 14-day sequential therapy
Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after14-day sequential therapy
Interventions: First line therapy: eligible patients will be randomized into one of the two groups.
Group (A): probiotic plus 14-day sequential therapy D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Group (B): placebo plus 14-day sequential therapy D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Follow-up
- The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut flora
- The body weight, waist and hip circumference and serum lipid profile, sugar, and HBA1C levels will be collected before , and 2 and 8 weeks and 1 year after eradication therapy
- Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of antibiotics. Mutations in 23S rRNA will also be determined by PCR followed by direct sequencing
Outcome Measurement:
Primary End Point: Incidence of adverse effects in the first line therapy in the two treatment groups
Secondary End Point:
- Eradication rates in the first line treatment in the two treatment groups
- Changes of gut microbiota in the two treatment groups
- Antibiotic resistance of gut flora after first line treatments in the two treatment groups
- Re-infection rate one year after eradication therapy
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Vigiis 101-LAB and sequential therapy, Placebo and sequential therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vigiis 101-LAB and sequential therapyDrug
Vigiis 101-LAB is the probiotic containing Lactobacillus paracasei subsp. Paracasei, which is the isolate from Taiwanese by Prof. Pan. This strain is resistant to gastric acid and bile acid. Therefore, its survival rate in the gastrointestinal tract could be as high as 95%. Previous studies showed that Vigiis 101-LAB can modulate the gut microbiota, with 10% increase in Bifidobacterium species and 20% reduction in Clostridium difficile.
Placebo and sequential therapyDrug
Placebo without Vigiis 101-LAB component
| Study group | Role | What they receive |
|---|---|---|
| probiotic plus 14-day sequential therapy | Experimental | D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days Receives: Drug: Vigiis 101-LAB and sequential therapy |
| placebo plus 14-day sequential therapy | Placebo comparator | D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days Receives: Drug: Placebo and sequential therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of adverse effects in the first line therapy in the two treatment groups
At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events and compliance at the end of treatment. Patients with low compliance as defined by taking less than 80% of the pills and those lost to follow up will be excluded from the per-protocol analysis.
Measured: 8 weeks
Secondary outcomes (1)
Eradication rates in the first line treatment in the two treatment groups
Urea breath testing will be done at least 6 weeks after completion of eradication therapy.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start29 Aug 2018
- Primary completion31 Jul 2019 (estimated)
- Study completion31 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722433
- Sponsor's protocol ID
- 201706036MIPA
- Status last verified
- Jun 2018
- First submitted
- 25 Oct 2018
- Last updated
- 31 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Probiotic Supplementation in the Reduction of Adverse Effects and Dysbiosis of Helicobacter Pylori Eradication Therapy - A Double Blind, Multi-center Randomized, Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03722433
- Acronym / sponsor ID
- 201706036MIPA
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 31 Jul 2019 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 29 Oct 2018 (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 investigators aimed to assess the effect of probiotic supplementation with Vigiis 101-LAB during H. pylori eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Detailed description
Backgroud: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and the recurrence rate of peptic ulcer disease. However, the adverse effects, such as diarrhea and abdominal pain occurred in about 20-30% of patient during eradication therapies for H. pylori. Dysbiosis of the gut microbiota might contribute to the adverse effects.
Aims: Therefore, the investigators aimed to assess the efficacy of probiotic supplementation during the eradication therapy with 14-day sequential therapy in the reduction of adverse effects and the restoration of the dysbiosis.
Methods:
This will be a double-blind, placebo controlled, multi-center randomized trial. 200 patients with H. pylori infection naïve to eradication therapy will be enrolled.
Before First Line Treatment: Any two positive of CLO test, histology, serology and culture or a positive UBT will be considered as H. pylori infected.
After First Line Treatment: C13-UBT will be used to assess the existence of H. pylori 6-8 weeks after 14-day sequential therapy
Long term reinfection: C13-UBT will be used to assess the recurrence of H. pylori 1 year after14-day sequential therapy
Interventions: First line therapy: eligible patients will be randomized into one of the two groups.
Group (A): probiotic plus 14-day sequential therapy D1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Group (B): placebo plus 14-day sequential therapy D1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days
Follow-up
- The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut flora
- The body weight, waist and hip circumference and serum lipid profile, sugar, and HBA1C levels will be collected before , and 2 and 8 weeks and 1 year after eradication therapy
- Determination of antibiotic resistance of H. pylori: Agar dilution test will be used to determine the minimum inhibitory concentrations of antibiotics. Mutations in 23S rRNA will also be determined by PCR followed by direct sequencing
Outcome Measurement:
Primary End Point: Incidence of adverse effects in the first line therapy in the two treatment groups
Secondary End Point:
- Eradication rates in the first line treatment in the two treatment groups
- Changes of gut microbiota in the two treatment groups
- Antibiotic resistance of gut flora after first line treatments in the two treatment groups
- Re-infection rate one year after eradication therapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotic plus 14-day sequential therapy | Experimental | Drug: Vigiis 101-LAB and sequential therapyD1-D56: probiotics 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days |
| placebo plus 14-day sequential therapy | Placebo comparator | Drug: Placebo and sequential therapyD1-D56: placebo 1 pack bid for 56 days D1-D7: (esomeprazole + amoxicillin bid) for 7 days D8-D14: (esomeprazole + clarithromycin + metronidazole bid) for another 7 days |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged greater than 20 years with H. pylori infection naïve to treatment are considered eligible for enrollment.
Key exclusion criteria (9 listed)
- children and teenagers aged less than 20 years
- history of gastrectomy
- gastric malignancy, including adenocarcinoma and lymphoma
- previous allergic reaction to antibiotics (amoxicillin, metronidazole, clarithromycin, probiotics) and PPI (esomeprazole)
- contraindication to treatment drugs
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 |
|---|---|---|
| Vigiis 101-LAB and sequential therapyVigiis 101-LAB is the probiotic containing Lactobacillus paracasei subsp. Paracasei, which is the isolate from Taiwanese by Prof. Pan. This strain is resistant to gastric acid and bile acid. Therefore, its survival rate in the gastrointestinal tract could be as high as 95%. Previous studies showed that Vigiis 101-LAB can modulate the gut microbiota, with 10% increase in Bifidobacterium species and 20% reduction in Clostridium difficile. | Drug | probiotic plus 14-day sequential therapy |
| Placebo and sequential therapyPlacebo without Vigiis 101-LAB component | Drug | placebo plus 14-day sequential therapy |
Primary outcome
Incidence of adverse effects in the first line therapy in the two treatment groups
Time frame: 8 weeks
At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events and compliance at the end of treatment. Patients with low compliance as defined by taking less than 80% of the pills and those lost to follow up will be excluded from the per-protocol analysis.
1 secondary outcome
Eradication rates in the first line treatment in the two treatment groups
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vigiis 101-LAB and sequential therapy in people with Helicobacter Pylori Infection, run by National Taiwan 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 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 31 Oct 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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, MD (23123456 ext. 63541, jyhmingliou@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse effects in the first line therapy in the two treatment groups (time frame: 8 weeks). 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 31 Oct 2018.