Effect of Probiotics on Helicobacter Pylori Eradication

December 2, 2019 updated by: Hangzhou Grand Biologic Pharmaceutical, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
238

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China
        • Recruiting
        • The First Affiliated Hospital of Nanchang University
        • Contact:
          • Nonghua Lv, master
    • Shanxi
      • Xi'an, Shanxi, China
        • Recruiting
        • Xi'an Central Hospital
        • Contact:
          • Kun Zhuang, master

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Voluntarily signing the informed consent form;
  2. Aged 18-65 years old(including 65), male or female;
  3. Patients aged 35-65 years old(including 35) with positive Helicobacter pylori should undergo gastroscopy, and the gastroscopy report shows normal or chronic gastritis;
  4. 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.

Exclusion Criteria:

  1. Gastroscopy report or previous medical history showed significant esophagus-gastric diseases, including gastric cancer, peptic ulcer, oesophagitis and esophageal erosion;
  2. Patients with chronic diarrhea and chronic functional constipation;
  3. 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;
  4. Abnormal stool routine results: fecal occult blood (+) or white blood cells (+);
  5. Patients with severe psychological or mental diseases;
  6. Those with a history of drug abuse or alcohol abuse;
  7. Those who are allergic to the drugs in this study;
  8. Those who have received Helicobacter pylori eradication therapy;
  9. 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.
  10. Pregnant or lactating women;
  11. Participating or after completing other clinical trials Less than 3 months;
  12. Others who researchers consider unsuitable for inclusion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: probiotics plus standard therapy
Drug: Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy
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.
Placebo Comparator: placebo plus standard therapy
Drug: Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
baseline, 28 days, 182days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
the incidence rate of various digestive tract related symptoms
Time Frame: baseline, 28 days, 182days
to calculate incidence rate of various digestive tract related symptoms including diarrhea, constipation, and other symptoms mentioned above
baseline, 28 days, 182days
duration of various digestive tract related symptoms
Time Frame: baseline, 28 days, 182days
to calculate duration of various digestive tract related symptoms including diarrhea, constipation, and other symptoms mentioned above
baseline, 28 days, 182days
stool frequency
Time Frame: baseline, 28 days, 182days
to evaluate the defecation frequency of diarrhea and constipation
baseline, 28 days, 182days
changes in intestinal flora
Time Frame: baseline, 14 days, 28 days, 70 days, 182days
to evaluate the changes of intestinal flora during the clinical study period
baseline, 14 days, 28 days, 70 days, 182days
changes in gastric flora
Time Frame: baseline, 70 days
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.
baseline, 70 days
Helicobacter pylori eradication rate
Time Frame: 70 days
to evaluate the results of 13C-urea breath test
70 days
adverse events
Time Frame: 28 days,182 days
Adverse events are assessed during the clinical study period.
28 days,182 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Grand Biologic Pharmaceutical, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The First Affiliated Hospital of Nanchang University
Xi'an Central Hospital
Nanjing First Hospital, Nanjing Medical University
Fifth Affiliated Hospital of Zhengzhou University
Renmin Hospital of Wuhan University
The First Affiliated Hospital of Shanxi Medical University
The First People's Hospital of Yunnan
Zhejiang Provincial Hospital of TCM

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nonghua Lv, master, The First Affiliated Hospital of Nanchang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 17, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 4, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 2, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HangzhouGrand

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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