Gastric CancerPhase 4NCT04660123
A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
A Phase 4 study testing Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication in people with Gastric Cancer and Helicobacter Pylori Infection, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
To observe the eradication rate of H. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gastric Cancer, Helicobacter Pylori Infection, Bismuth
- What is being tested?
- Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 959 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2020to 30 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18~75,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
- Patients are willing to receive eradication treatment.
- Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Who cannot join
- Contraindications to study drugs.
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
- Pregnant or lactating women.
- Underwent upper gastrointestinal Surgery.
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- Patients with Barrett esophageal or highly atypical hyperplasia, have symptom of dysphagia.
- Evidence of bleeding or iron efficiency anemia.
- A history of malignancy.
- Drug or alcohol abuse history in the past 1 year.
- Systemic use of corticosteroids, non steroidal anti-inflammatory drugs,anticoagulants, platelet aggregation inhibitors (except the use of aspirin for less than 100 mg/d).
- Patients who has psychological problem or poor compliance.
- Enrolled in other clinical trials in the past 3 months.
- Refuse to sign informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
To observe the eradication rate of H. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.
Read the detailed description
The study will include three phases: screening, treatment and follow-up. Screening: Patients who have been screened to meet the criteria for naval platooning will be enrolled after signing an informed consent form.
Treatment: Subjects will receive 14 days of eradication treatment. With the exception of colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (PPI) and 2 antibiotics will be selected on the basis of the physician's experience.
Follow-up: Includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
- Conditions
- Gastric Cancer, Helicobacter Pylori Infection, Bismuth
- Being tested
- Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori EradicationDrug
Standard dose of proton pump inhibitor, bismuth , and 2 antibiotics, 14 days course.
Standard doses of proton pump inhibitors are esomeprazole 20mg, rabeprazole 10mg (or 20mg).
Omeprazole 20mg, lansoprazole 30mg, pantoprazole 40mg, alprazole 5mg, any one of these.
Bismuth is colloidal bismuth pellets, 150mg, 2 times/d.
Antibiotic Program:
Scheme 1 Amoxicillin 1000 mg, 2 times/d; Clarithromycin 500mg, 2 times per day Scheme 2 Amoxicillin 1000 mg, 2 times/d; Levofloxacin 5001 times/2 times Scheme 3 Amoxicillin 1000 mg, 2 times/d; Furazolidone 100mg, 2 times/d. Scheme 4 Amoxicillin 1000 mg, 2 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 5 Amoxicillin 1000 mg, 2 times/d; Tetracycline 500mg, 3 times/d or 4 times/d Scheme 6 Tetracycline 500mg, 3 times/d or 4 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 7 Tetracycline 500mg, 3 times/d or 4 times/d; Furazolidone 100mg, 2 times/d.
| Study group | Role | What they receive |
|---|---|---|
| Quadruple therapy with colloidal bismuth pectin granules | Experimental | colloidal bismuth pectin granules 150 mg, Selection of 2 antibiotics and 1 proton pump inhibitor based on China's fifth national consensus report on the management of H. pylori infection.All medication is taken orally, twice a day. Receives: Drug: Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication |
What is being measured
The primary outcome is the main question the study is designed to answer.
helicobacter pylori eradication
The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication.
Measured: 28 days after treatment
Secondary outcomes (1)
symptoms improvement rates
symptoms improvement rates Evaluation improvement rate of symptoms 2 weeks of treatment and 4 weeks after the end of treatment. Symptom improvement rate =#total score before treatment - total score after treatment#/total score before treatment x100%. Total score = frequency + severity.Frequency score is calculated by all the frequency of heartburn, reflux, abdominal pain, and flatulence, etc. Severity is accumulated by the degree of symptoms described above, which is divided to 4 degree as 0 presenting none, and 3 presenting most severe
Measured: 14 days of treatment, and 28 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2020
- Study start20 Dec 2020
- Primary completion30 Dec 2021
- Study completion30 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 959 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04660123
- Sponsor's protocol ID
- KY20202101-F-1
- Status last verified
- Jan 2023
- First submitted
- 2 Dec 2020
- Last updated
- 31 Jan 2023
- 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 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Real World Study of Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication
- ClinicalTrials.gov ID
- NCT04660123
- Acronym / sponsor ID
- KY20202101-F-1
- Conditions
- Gastric Cancer, Helicobacter Pylori Infection, Bismuth
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 959 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 20 Dec 2020 (actual)
- Primary completion
- 30 Dec 2021 (actual)
- Study completion
- 30 Dec 2021 (actual)
- First posted
- 9 Dec 2020 (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.
To observe the eradication rate of H. pylori infection, symptom improvement and the incidence of adverse effects in patients using a bismuth colloidal pectin granules quadruple therapy.
Detailed description
The study will include three phases: screening, treatment and follow-up. Screening: Patients who have been screened to meet the criteria for naval platooning will be enrolled after signing an informed consent form.
Treatment: Subjects will receive 14 days of eradication treatment. With the exception of colloidal bismuth pectin granules, which will be limited, proton pump inhibitors (PPI) and 2 antibiotics will be selected on the basis of the physician's experience.
Follow-up: Includes two visits. approximately 14 days of treatment and 28 days after the end of treatment. Eradication of H. Pylori will be confirmed through urea breath test(UBT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Quadruple therapy with colloidal bismuth pectin granules | Experimental | Drug: Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradicationcolloidal bismuth pectin granules 150 mg, Selection of 2 antibiotics and 1 proton pump inhibitor based on China's fifth national consensus report on the management of H. pylori infection.All medication is taken orally, twice a day. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age between 18~75,both gender.
- Patients with upper gastrointestinal symptoms and with documented H.pylori infection.
- Patients are willing to receive eradication treatment.
- Women are eligible if they are not pregnant or nursing, and if they are of childbearing potential they are required to use medically acceptable contraception for the duration of the study and 30 days thereafter.
Key exclusion criteria (14 listed)
- Contraindications to study drugs.
- Substantial organ impairment, severe or unstable cardiopulmonary or endocrine disease.
- Constant use of anti-ulcer drugs ( including taking proton-pump.inhibitors(PPI) within 2 weeks before the [13C] urea breath test),antibiotics or bismuth complexes (more than 3 times /1 month before screening).
- Patients were diagnosed with gastroduodenal ulcer and MALTlymphoma.
- Pregnant or lactating women.
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 |
|---|---|---|
| Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori EradicationStandard dose of proton pump inhibitor, bismuth , and 2 antibiotics, 14 days course. Standard doses of proton pump inhibitors are esomeprazole 20mg, rabeprazole 10mg (or 20mg). Omeprazole 20mg, lansoprazole 30mg, pantoprazole 40mg, alprazole 5mg, any one of these. Bismuth is colloidal bismuth pellets, 150mg, 2 times/d. Antibiotic Program: Scheme 1 Amoxicillin 1000 mg, 2 times/d; Clarithromycin 500mg, 2 times per day Scheme 2 Amoxicillin 1000 mg, 2 times/d; Levofloxacin 5001 times/2 times Scheme 3 Amoxicillin 1000 mg, 2 times/d; Furazolidone 100mg, 2 times/d. Scheme 4 Amoxicillin 1000 mg, 2 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 5 Amoxicillin 1000 mg, 2 times/d; Tetracycline 500mg, 3 times/d or 4 times/d Scheme 6 Tetracycline 500mg, 3 times/d or 4 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 7 Tetracycline 500mg, 3 times/d or 4 times/d; Furazolidone 100mg, 2 times/d. | Drug | Quadruple therapy with colloidal bismuth pectin granules |
Primary outcome
helicobacter pylori eradication
Time frame: 28 days after treatment
The primary end point of this study is H.pylori eradication,established by negative [13C] urea breath test 28 days after the end of eradication.
1 secondary outcome
symptoms improvement rates
Time frame: 14 days of treatment, and 28 days after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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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 Phase 4 study testing Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication in people with Gastric Cancer and Helicobacter Pylori Infection, run by Xijing Hospital of Digestive Diseases at 1 site 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 14 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: finished, as of the sponsor's last update on 31 Jan 2023. 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 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
helicobacter pylori eradication (time frame: 28 days after treatment). 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 Jan 2023.