Helicobacter Pylori EradicationPhase 4NCT04034641
Effect of Probiotics on Helicobacter Pylori Eradication
A Phase 4 study testing Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy in people with Helicobacter Pylori Eradication, run by Hangzhou Grand Biologic Pharmaceutical, Inc. at 2 sites in China.
Trial summary
The purpose of this clinical trial is to evaluate the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions of Helicobacter pylori quadruple eradication therapy and its influence on gastrointestinal flora. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Helicobacter Pylori Eradication
- What is being tested?
- Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 2 sitesChina
- Study dates
- 17 Jun 2019to 31 Dec 2021
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signing the informed consent form;
- Aged 18-65 years old(including 65), male or female;
- Patients aged 35-65 years old(including 35) with positive Helicobacter pylori should undergo gastroscopy, and the gastroscopy report shows normal or chronic gastritis;
- Patients aged 18-35 years (including 18) with positive Helicobacter pylori are not required to perform gastroscopy examination if there is no obvious clinical symptoms, or applying report of gastroscopy within 6 months showing normal or chronic gastritis.
Who cannot join
- Gastroscopy report or previous medical history showed significant esophagus-gastric diseases, including gastric cancer, peptic ulcer, oesophagitis and esophageal erosion;
- Patients with chronic diarrhea and chronic functional constipation;
- Other systemic diseases, including cardiovascular diseases, lung diseases, liver diseases (transaminase index is more than 2 times higher than the normal value), kidney diseases (creatinine index is higher than the normal value) and other important organs with severe lesions, severe metabolic diseases (diabetes, thyroid diseases), malignant tumors, and severe immune system diseases;
- Abnormal stool routine results: fecal occult blood (+) or white blood cells (+);
- Patients with severe psychological or mental diseases;
- Those with a history of drug abuse or alcohol abuse;
Show all 12Show fewer
- Those who are allergic to the drugs in this study;
- Those who have received Helicobacter pylori eradication therapy;
- Drugs which affect the intestinal flora(including antibacterial drugs, microecological preparations, intestinal mucosal protectors, Chinese patent medicines, etc.) have been used in the past 1 month or need to be used continuously for more than 1 week in the experiment.
- Pregnant or lactating women;
- Participating or after completing other clinical trials Less than 3 months;
- Others who researchers consider unsuitable for inclusion.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Nonghua Lv, master
- Recruiting
Xi'an Central Hospital
Xi’an, Shanxi
Kun Zhuang, master
About this study
Official title: Clinical Study on Bifidobacterium Quadruple Live Bacteria Tablets (Si Lian Kang) Reducing the Incidence Rate of Adverse Reactions in Helicobacter Pylori Quadruple Eradication Therapy and on the Effects of Gastrointestinal Flora
The purpose of this clinical trial is to evaluate the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions of Helicobacter pylori quadruple eradication therapy and its influence on gastrointestinal flora.
Read the detailed description
Bismuth agent quadruple therapy (including bismuth agent and proton pump inhibitor combined with two antibiotics) is the first-line strategy to eradicate Helicobacter pylori in China. However, it may cause a series of adverse reactions, such as nausea, diarrhea, abdominal pain, constipation, and abnormal taste, etc., which leads to a decrease in patient compliance, thereby affecting the treatment effect. Many studies have found that adding probiotics to traditional Helicobacter pylori eradication therapies increase eradication rates and reduce the side effects of the treatment. Bifidobacterium tetrad live bacteria tablet is a compound microecological preparation composed of bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus. This study aims to observe the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions in Helicobacter pylori quadruple eradication therapy and on the effects of gastrointestinal flora.
- Conditions
- Helicobacter Pylori Eradication
- Being tested
- Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy, Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapyDrug
On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Probiotic: Bifidobacterium tetrad live bacteria tablets should be taken at noon once a day (30 min after meal ), 9 tablets per time. On day 15-28: Probiotic: Bifidobacterium tetrad live bacteria tablets, taken at noon once a day (30min after meal), 9 tablets per time.
Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapyDrug
On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Placebo: Bifidobacterium tetrad live bacteria tablet placebos should be taken at noon once a day ( 30 min after meal ), 9 tablets per time. On day 15-28: Placebo: Bifidobacterium tetrad live bacteria tablet placebos, taken at noon once a day (30min after meal), 9 tablets per time.
| Study group | Role | What they receive |
|---|---|---|
| probiotics plus standard therapy | Experimental | Not described Receives: Drug: Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy |
| placebo plus standard therapy | Placebo comparator | Not described Receives: Drug: Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the total incidence rate of digestive tract related adverse reactions
The patient diary cards (including Bristol stool classification, diarrhea, constipation, abdominal pain, abdominal distension, belching, nausea, vomiting, loss of appetite and changes in taste) are filled in daily from the -14th day to 28th day. The above contents are recorded weekly from the 29th to182th day. to calculate the total incidence rate of digestive tract related adverse reactions mentioned above
Measured: baseline, 28 days, 182days
Secondary outcomes (7)
the incidence rate of various digestive tract related symptoms
to calculate incidence rate of various digestive tract related symptoms including diarrhea, constipation, and other symptoms mentioned above
Measured: baseline, 28 days, 182days
duration of various digestive tract related symptoms
to calculate duration of various digestive tract related symptoms including diarrhea, constipation, and other symptoms mentioned above
Measured: baseline, 28 days, 182days
stool frequency
to evaluate the defecation frequency of diarrhea and constipation
Measured: baseline, 28 days, 182days
changes in intestinal flora
to evaluate the changes of intestinal flora during the clinical study period
Measured: baseline, 14 days, 28 days, 70 days, 182days
changes in gastric flora
20 patients are enrolled in the experiment group and control group respectively. Mucosal samples (one gastric antrum and one gastric body) are taken by gastroscopy before treatment. Gastroscope was reexamined 6 weeks after probiotics or placebo withdrawal (the 70th day), and mucosal samples (one gastric antrum and one gastric body) are taken.
Measured: baseline, 70 days
Helicobacter pylori eradication rate
to evaluate the results of 13C-urea breath test
Measured: 70 days
adverse events
Adverse events are assessed during the clinical study period.
Measured: 28 days,182 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start17 Jun 2019
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori EradicationStudies of the same condition, open and under way.
- 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 238 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Nanchang University, The First People's Hospital of Yunnan, Zhejiang Provincial Hospital of TCM, The First Affiliated Hospital of Zhengzhou University, Nanjing First Hospital, Nanjing Medical University, Xi'an Central Hospital, The First Affiliated Hospital of Shanxi Medical University, Renmin Hospital of Wuhan University
- Responsible party
- Sponsor
- Investigators
- Nonghua Lv, master, Principal investigator, The First Affiliated Hospital of Nanchang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034641
- Sponsor's protocol ID
- HangzhouGrand
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 4 Dec 2019
- 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 4 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on Bifidobacterium Quadruple Live Bacteria Tablets (Si Lian Kang) Reducing the Incidence Rate of Adverse Reactions in Helicobacter Pylori Quadruple Eradication Therapy and on the Effects of Gastrointestinal Flora
- ClinicalTrials.gov ID
- NCT04034641
- Acronym / sponsor ID
- HangzhouGrand
- Conditions
- Helicobacter Pylori Eradication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Nanchang University, The First People's Hospital of Yunnan, Zhejiang Provincial Hospital of TCM, The First Affiliated Hospital of Zhengzhou University, Nanjing First Hospital, Nanjing Medical University, Xi'an Central Hospital, The First Affiliated Hospital of Shanxi Medical University, Renmin Hospital of Wuhan University
- Study start
- 17 Jun 2019 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 26 Jul 2019 (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 purpose of this clinical trial is to evaluate the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions of Helicobacter pylori quadruple eradication therapy and its influence on gastrointestinal flora.
Detailed description
Bismuth agent quadruple therapy (including bismuth agent and proton pump inhibitor combined with two antibiotics) is the first-line strategy to eradicate Helicobacter pylori in China. However, it may cause a series of adverse reactions, such as nausea, diarrhea, abdominal pain, constipation, and abnormal taste, etc., which leads to a decrease in patient compliance, thereby affecting the treatment effect. Many studies have found that adding probiotics to traditional Helicobacter pylori eradication therapies increase eradication rates and reduce the side effects of the treatment. Bifidobacterium tetrad live bacteria tablet is a compound microecological preparation composed of bifidobacterium infantis, lactobacillus acidophilus, enterococcus faecalis and bacillus cereus. This study aims to observe the clinical efficacy of Bifidobacterium quadruple live bacteria tablets (Si Lian Kang) on reducing the incidence rate of adverse reactions in Helicobacter pylori quadruple eradication therapy and on the effects of gastrointestinal flora.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| probiotics plus standard therapy | Experimental | Drug: Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy |
| placebo plus standard therapy | Placebo comparator | Drug: Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntarily signing the informed consent form;
- Aged 18-65 years old(including 65), male or female;
- Patients aged 35-65 years old(including 35) with positive Helicobacter pylori should undergo gastroscopy, and the gastroscopy report shows normal or chronic gastritis;
- Patients aged 18-35 years (including 18) with positive Helicobacter pylori are not required to perform gastroscopy examination if there is no obvious clinical symptoms, or applying report of gastroscopy within 6 months showing normal or chronic gastritis.
Key exclusion criteria (12 listed)
- Gastroscopy report or previous medical history showed significant esophagus-gastric diseases, including gastric cancer, peptic ulcer, oesophagitis and esophageal erosion;
- Patients with chronic diarrhea and chronic functional constipation;
- Other systemic diseases, including cardiovascular diseases, lung diseases, liver diseases (transaminase index is more than 2 times higher than the normal value), kidney diseases (creatinine index is higher than the normal value) and other important organs with severe lesions, severe metabolic diseases (diabetes, thyroid diseases), malignant tumors, and severe immune system diseases;
- Abnormal stool routine results: fecal occult blood (+) or white blood cells (+);
- Patients with severe psychological or mental diseases;
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 |
|---|---|---|
| Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapyOn day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Probiotic: Bifidobacterium tetrad live bacteria tablets should be taken at noon once a day (30 min after meal ), 9 tablets per time. On day 15-28: Probiotic: Bifidobacterium tetrad live bacteria tablets, taken at noon once a day (30min after meal), 9 tablets per time. | Drug | probiotics plus standard therapy |
| Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapyOn day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Placebo: Bifidobacterium tetrad live bacteria tablet placebos should be taken at noon once a day ( 30 min after meal ), 9 tablets per time. On day 15-28: Placebo: Bifidobacterium tetrad live bacteria tablet placebos, taken at noon once a day (30min after meal), 9 tablets per time. | Drug | placebo plus standard therapy |
Primary outcome
the total incidence rate of digestive tract related adverse reactions
Time frame: baseline, 28 days, 182days
The patient diary cards (including Bristol stool classification, diarrhea, constipation, abdominal pain, abdominal distension, belching, nausea, vomiting, loss of appetite and changes in taste) are filled in daily from the -14th day to 28th day. The above contents are recorded weekly from the 29th to182th day. to calculate the total incidence rate of digestive tract related adverse reactions mentioned above
7 secondary outcomes
the incidence rate of various digestive tract related symptoms
Time frame: baseline, 28 days, 182days
duration of various digestive tract related symptoms
Time frame: baseline, 28 days, 182days
stool frequency
Time frame: baseline, 28 days, 182days
changes in intestinal flora
Time frame: baseline, 14 days, 28 days, 70 days, 182days
changes in gastric flora
Time frame: baseline, 70 days
Helicobacter pylori eradication rate
Time frame: 70 days
adverse events
Time frame: 28 days,182 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2019.
Related trials for Helicobacter Pylori Eradication
RecruitingPhase 3
Keverprazan-Minocycline Dual Therapy of Different Durations Versus Bismuth Quadruple Therapy for Helicobacter Pylori Eradication.
Helicobacter Infection
RecruitingPhase 1
Impact of Eradication Therapy on Helicobacter Pylori Infection With Chronic Obstructive Pulmonary Disease:
Chronic Obstructive Pulmonary Disease (COPD), With Poitive H Pylori
RecruitingPhase 4
Efficacy and Safety of Linarazen Gluconate Capsules Combined With Amoxicillin (Dual-Drug Therapy) Versus Bismuth-Containing Quadruple Therapy for First-Line Eradication of Helicobacter Pylori Infection
HELICOBACTER PYLORI INFECTIONS
Not yet recruitingPhase 3
Efficacy and Safety of JP-1366-based Triple Therapy in Helicobacter Pylori-positive Subjects
H. Pylori Eradication Therapy
Not yet recruitingPhase 3
Personalized vs Standard of Care Treatment for Helicobacter Pylori Eradication Among Veterans
Helicobacter Pylori
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.
Nonghua Lv, master principal investigator
The First Affiliated Hospital of Nanchang University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy in people with Helicobacter Pylori Eradication, run by Hangzhou Grand Biologic Pharmaceutical, Inc. at 2 sites in China.
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 4 inclusion and 12 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. 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 Lu Zhang, master (+8615901365519, zhanglu@hzydsw.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the total incidence rate of digestive tract related adverse reactions (time frame: baseline, 28 days, 182days). 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 4 Dec 2019.