Helicobacter Pylori InfectionPhase 1/2NCT06823791
Furazolidone Quadruple Regimen Eradicate H. Pylori Infection
A Phase 1/2 study testing Furazolidone and Clarithromycin in people with Helicobacter Pylori Infection and Eradication, run by Liaocheng People's Hospital at 1 site in China.
Trial summary
Research protocol: Experimental group: First line solution (furazolidone regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + furazolidone 100 mg, twice daily, for 14 days. Patients who is still positive for H. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Eradication
- What is being tested?
- Furazolidone and Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 493 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2022to 30 Jul 2024
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- H Pylori infection: 13C/14C urea breath test positive or rapid urease test positive or gastric mucosal tissue pathological section HE staining positive or gastric mucosal tissue H. Pylori culture positive or fecal Positive detection of H pylori antigen
- No previous History of eradication treatment for H pylori;
- Age 18-70 years old;
Who cannot join
- Pregnant or lactating women;
- There are also other serious diseases that affect the evaluation of this study, such as severe coronary heart disease, liver disease, kidney disease, chronic obstructive pulmonary disease, malignant tumors, and psychological disorders;
- Individuals with a history of significant or complex gastrointestinal surgery;
- Individuals who are allergic to the drugs used in this study;
- Unable to cooperate with this experimenter.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Furazolidone Containing Quadruple Therapy for First-line Helicobacter Pylori Eradication
Research protocol:
Experimental group:
Read more
First line solution (furazolidone regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + furazolidone 100 mg, twice daily, for 14 days.
Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days.
Control group:
First line solution (clarithromycin regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + clarithromycin 500 mg, twice a day, for 14 days.
Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days.
Main study endpoint:
The difference in the eradication rate of H. pylori infection between the furazolidone quadruple regimen and the clarithromycin quadruple regimen.
Secondary study endpoint:
- Safety and compliance of the furazolidone quadruple regimen.
- Comparison of high-dose dual therapy with furazolidone quadruple therapy and clarithromycin quadruple therapy on H. pylori eradication rate.
- 1-year recurrence and recurrence rate of H. pylori infection.
Read the detailed description
Patients A total of 500 patients with primary H pylori infection were collected from Liaocheng People's Hospital from August 2022 to July 2024. These patients were from outpatient clinics, followed up by using telephone to monitor drugs, adverse reactions, symptom improvement before and after medication. Written informed consent was obtained from all participated patients in this study. This study was approved by the local research ethics committee at the Liaocheng Hospital according to the principle of the Helsinki Declaration II (No. 2023110). Patients were randomly divided into FZD group and CLA group. Inclusion criteria include: 1. Hp test positive. 2. age range from 18 to 70 years. 3. without previously Hp eradication treatment prior to enrollment. Exclusion criteria were as follows: 1. severe concomitant diseases such as cardiac dysfunction, liver, kidney et al. 2. planning to be or being pregnant, or lactating. 3. history of allergy to any medicines used in this study. 4. lost in follow-up.
Drugs Drugs used in this study were as follows: FZD was from Shanghai Yurui Biotechnology Pharmaceutical Co., Ltd. Esomeprazole was from AstraZeneca Pharmaceutical Co. Ltd, England; AMX was from Shandong LuKang Pharmaceutical Co., Ltd; Bismuth potassium citrate was from Shanghai Modern Hassen Pharmaceutical Co., Ltd. CLA was from Guangdong DongYangGuang Pharmaceutical Co., Ltd. All drugs were routinely prescribed in hospital pharmacy.
Determination of Hp infection The status of Hp infection was determined by methods as follows: 1. 13C/14C urea breath test (UBT) 2. rapid urease test (RUT) 3. HE staining of gastric mucosal histopathological sections 4. gastric mucosal Hp culture 5. fecal Hp antigen test. Post-treatment Hp status was assessed 4 weeks after finishing the treatment. Hp was considered eradicated if post-treatment Hp was negative. If the result was positive, it was retested again after half a year. If the retested result was still positive, Hp eradication failed.
Hp eradication regimens and duration Patients were randomly allocated into FZD and CLA groups. The FZD group includes FZD (100mg, bid), esomeprazole (20mg, bid), bismuth potassium citrate (220mg, bid), and AMX (1000mg, bid) for 14 days. In the CLA group, FZD was replaced by CLA (500mg, bid), and the other drugs were the same. Esomeprazole and bismuth were taken 30 minutes before meal, AMX, CLA, and FZD were taken 30 minutes after meal.
Evaluation of adverse effects and symptom improvement after treatment Drugs, adverse effects, improvement of clinical symptoms were recorded by outpatient questionnaire. Adverse drug reactions include abdominal pain, bloating, diarrhea, constipation, nausea, changes in taste (bad oral taste), rash, insomnia, arthralgia, headache, dizziness, fatigue, peripheral nerve damage. The adverse events were classified as yes or no. The symptoms before and after treatment was evaluated by the Likert rating scale. Symptoms are classified as none (1 point), mild (2 points, almost no symptoms), moderate (3 points, tolerable, not affect daily activities), severe (4 points, affect daily activities), and serious (5 points, need to be hospitalized or intervened to prevent permanent injury or even death). Frequency includes: none (1 point), less than 2 times a week (2 points), more than 3 times a week and not daily (3 points), daily but intermittent (4 points), almost constant daily (5 points). Total score = frequency×symptom.
Cost-effectiveness analysis Cost (C) is the total cost of each regimen of drugs. Effectiveness (E) represents therapeutic effect of a regimen. In this study, cost-effectiveness ratio (C/E) and incremental cost-effectiveness ratio were used to evaluate the cost-effectiveness analysis. Incremental cost-effectiveness ratio (DC/DE) referred to the ratio of cost difference to effectiveness between FZD group and CLA group; which means the cost of each unit effect increased by former scheme.
- Conditions
- Helicobacter Pylori Infection, Eradication
- Being tested
- Furazolidone, Clarithromycin
- Keywords
- H. pylori eradication, furazolidone quadruple regimen, clarithromycin quadruple regimen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FurazolidoneDrug
Also called esomeprazole magnesium, colloidal bismuth pectin, amoxicillin
esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + furazolidone 100 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops.
ClarithromycinDrug
Also called esomeprazole magnesium, colloidal bismuth pectin, amoxicillin
esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + clarithromycin 500 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops.
| Study group | Role | What they receive |
|---|---|---|
| furazolidone regimen | Experimental | Patients who were enrolled in the experimental group use the furazolidone regimen esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid+ amoxicillin 1000 mg bid+ furazolidone 100 mg bid Receives: Drug: Furazolidone |
| Clarithromycin regimen | Active comparator | Patients who were enrolled in the control group use the clarithromycin regimen esomeprazole magnesium 20 mg bid+colloidal bismuth pectin 200mg bid+ amoxicillin 1000 mg bid+ clarithromycin 500 mg bid Receives: Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hp eradication rate
The status of Hp infection was determined by methods as follows: 1. 13C/14C urea breath test (UBT) 2. rapid urease test (RUT) 3. HE staining of gastric mucosal histopathological sections 4. gastric mucosal Hp culture 5. fecal Hp antigen test. Post-treatment Hp status was assessed 4 weeks after finishing the treatment. Hp was considered eradicated if post-treatment Hp was negative. If the result was positive, it was retested again after half a year. If the retested result was still positive, Hp eradication failed.
Measured: 6 months
Secondary outcomes (1)
adverse reactions
adverse effect was recorded by outpatient questionnaire. Adverse reactions include abdominal pain, abdominal distension, diarrhea, constipation, nausea, changes in taste (bad oral breath), rash, insomnia, arthralgia, headache, dizziness, fatigue, peripheral nerve damage.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study start1 Aug 2022
- Primary completion30 Jul 2024
- Study completion30 Jul 2024
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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A total of 500 patients with primary H pylori infection were collected from Liaocheng People's Hospital. Patients were randomly divided into FZD group and CLA group.
- Masking
- None (open label)
- Enrolment
- 493 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liaocheng People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, liulifeng, Liaocheng People's Hospital
- Investigators
- Lifeng Liu, Principal investigator, Liaocheng Peoples hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06823791
- Sponsor's protocol ID
- 1234567
- Status last verified
- Feb 2025
- First submitted
- 4 Sep 2023
- Last updated
- 12 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 12 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Furazolidone Containing Quadruple Therapy for First-line Helicobacter Pylori Eradication
- ClinicalTrials.gov ID
- NCT06823791
- Acronym / sponsor ID
- 1234567
- Conditions
- Helicobacter Pylori Infection, Eradication
- Keywords
- H. pylori eradication, furazolidone quadruple regimen, clarithromycin quadruple regimen
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 493 participants (actual)
- Lead sponsor
- Liaocheng People's HospitalUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 30 Jul 2024 (actual)
- Study completion
- 30 Jul 2024 (actual)
- First posted
- 12 Feb 2025 (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.
Research protocol:
Experimental group:
First line solution (furazolidone regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + furazolidone 100 mg, twice daily, for 14 days.
Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days.
Control group:
First line solution (clarithromycin regimen): esomeprazole magnesium 20 mg +colloidal bismuth pectin 200mg+ amoxicillin 1000 mg + clarithromycin 500 mg, twice a day, for 14 days.
Patients who is still positive for H. pylori infection after the first line solution select the second line solution (high-dose dual regimen): esomeprazole magnesium 20 mg and amoxicillin 750 mg, 4 times daily, for 14 days.
Main study endpoint:
The difference in the eradication rate of H. pylori infection between the furazolidone quadruple regimen and the clarithromycin quadruple regimen.
Secondary study endpoint:
- Safety and compliance of the furazolidone quadruple regimen.
- Comparison of high-dose dual therapy with furazolidone quadruple therapy and clarithromycin quadruple therapy on H. pylori eradication rate.
- 1-year recurrence and recurrence rate of H. pylori infection.
Detailed description
Patients A total of 500 patients with primary H pylori infection were collected from Liaocheng People's Hospital from August 2022 to July 2024. These patients were from outpatient clinics, followed up by using telephone to monitor drugs, adverse reactions, symptom improvement before and after medication. Written informed consent was obtained from all participated patients in this study. This study was approved by the local research ethics committee at the Liaocheng Hospital according to the principle of the Helsinki Declaration II (No. 2023110). Patients were randomly divided into FZD group and CLA group. Inclusion criteria include: 1. Hp test positive. 2. age range from 18 to 70 years. 3. without previously Hp eradication treatment prior to enrollment. Exclusion criteria were as follows: 1. severe concomitant diseases such as cardiac dysfunction, liver, kidney et al. 2. planning to be or being pregnant, or lactating. 3. history of allergy to any medicines used in this study. 4. lost in follow-up.
Drugs Drugs used in this study were as follows: FZD was from Shanghai Yurui Biotechnology Pharmaceutical Co., Ltd. Esomeprazole was from AstraZeneca Pharmaceutical Co. Ltd, England; AMX was from Shandong LuKang Pharmaceutical Co., Ltd; Bismuth potassium citrate was from Shanghai Modern Hassen Pharmaceutical Co., Ltd. CLA was from Guangdong DongYangGuang Pharmaceutical Co., Ltd. All drugs were routinely prescribed in hospital pharmacy.
Determination of Hp infection The status of Hp infection was determined by methods as follows: 1. 13C/14C urea breath test (UBT) 2. rapid urease test (RUT) 3. HE staining of gastric mucosal histopathological sections 4. gastric mucosal Hp culture 5. fecal Hp antigen test. Post-treatment Hp status was assessed 4 weeks after finishing the treatment. Hp was considered eradicated if post-treatment Hp was negative. If the result was positive, it was retested again after half a year. If the retested result was still positive, Hp eradication failed.
Hp eradication regimens and duration Patients were randomly allocated into FZD and CLA groups. The FZD group includes FZD (100mg, bid), esomeprazole (20mg, bid), bismuth potassium citrate (220mg, bid), and AMX (1000mg, bid) for 14 days. In the CLA group, FZD was replaced by CLA (500mg, bid), and the other drugs were the same. Esomeprazole and bismuth were taken 30 minutes before meal, AMX, CLA, and FZD were taken 30 minutes after meal.
Evaluation of adverse effects and symptom improvement after treatment Drugs, adverse effects, improvement of clinical symptoms were recorded by outpatient questionnaire. Adverse drug reactions include abdominal pain, bloating, diarrhea, constipation, nausea, changes in taste (bad oral taste), rash, insomnia, arthralgia, headache, dizziness, fatigue, peripheral nerve damage. The adverse events were classified as yes or no. The symptoms before and after treatment was evaluated by the Likert rating scale. Symptoms are classified as none (1 point), mild (2 points, almost no symptoms), moderate (3 points, tolerable, not affect daily activities), severe (4 points, affect daily activities), and serious (5 points, need to be hospitalized or intervened to prevent permanent injury or even death). Frequency includes: none (1 point), less than 2 times a week (2 points), more than 3 times a week and not daily (3 points), daily but intermittent (4 points), almost constant daily (5 points). Total score = frequency×symptom.
Cost-effectiveness analysis Cost (C) is the total cost of each regimen of drugs. Effectiveness (E) represents therapeutic effect of a regimen. In this study, cost-effectiveness ratio (C/E) and incremental cost-effectiveness ratio were used to evaluate the cost-effectiveness analysis. Incremental cost-effectiveness ratio (DC/DE) referred to the ratio of cost difference to effectiveness between FZD group and CLA group; which means the cost of each unit effect increased by former scheme.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A total of 500 patients with primary H pylori infection were collected from Liaocheng People's Hospital. Patients were randomly divided into FZD group and CLA group.
| Arm | Type | Receives |
|---|---|---|
| furazolidone regimen | Experimental | Drug: FurazolidonePatients who were enrolled in the experimental group use the furazolidone regimen esomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid+ amoxicillin 1000 mg bid+ furazolidone 100 mg bid |
| Clarithromycin regimen | Active comparator | Drug: ClarithromycinPatients who were enrolled in the control group use the clarithromycin regimen esomeprazole magnesium 20 mg bid+colloidal bismuth pectin 200mg bid+ amoxicillin 1000 mg bid+ clarithromycin 500 mg bid |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- H Pylori infection: 13C/14C urea breath test positive or rapid urease test positive or gastric mucosal tissue pathological section HE staining positive or gastric mucosal tissue H. Pylori culture positive or fecal Positive detection of H pylori antigen
- No previous History of eradication treatment for H pylori;
- Age 18-70 years old;
Key exclusion criteria (5 listed)
- Pregnant or lactating women;
- There are also other serious diseases that affect the evaluation of this study, such as severe coronary heart disease, liver disease, kidney disease, chronic obstructive pulmonary disease, malignant tumors, and psychological disorders;
- Individuals with a history of significant or complex gastrointestinal surgery;
- Individuals who are allergic to the drugs used in this study;
- Unable to cooperate with this experimenter.
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 |
|---|---|---|
| FurazolidoneAlso: esomeprazole magnesium, colloidal bismuth pectin, amoxicillinesomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + furazolidone 100 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops. | Drug | furazolidone regimen |
| ClarithromycinAlso: esomeprazole magnesium, colloidal bismuth pectin, amoxicillinesomeprazole magnesium 20 mg bid +colloidal bismuth pectin 200mg bid + amoxicillin 1000 mg bid + clarithromycin 500 mg bid, for 14 days. After stopping the medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months and 12 months, the experiment stop. If H. pylori is positive, check again after 6 months. If H. pylori is still positive, high-dose dual therapy will be used to resist H. pylori again. After stopping the second medication for 30 days, check the H. pylori again. If H. pylori is negative, check again after 6 months, and the experiment stops. If H. pylori is still positive, check again after 6 months, and the experiment stops. | Drug | Clarithromycin regimen |
Primary outcome
Hp eradication rate
Time frame: 6 months
The status of Hp infection was determined by methods as follows: 1. 13C/14C urea breath test (UBT) 2. rapid urease test (RUT) 3. HE staining of gastric mucosal histopathological sections 4. gastric mucosal Hp culture 5. fecal Hp antigen test. Post-treatment Hp status was assessed 4 weeks after finishing the treatment. Hp was considered eradicated if post-treatment Hp was negative. If the result was positive, it was retested again after half a year. If the retested result was still positive, Hp eradication failed.
1 secondary outcome
adverse reactions
Time frame: 1 month
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 12 Feb 2025.
- 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.
Lifeng Liu principal investigator
Liaocheng Peoples hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Furazolidone and Clarithromycin in people with Helicobacter Pylori Infection and Eradication, run by Liaocheng People's Hospital 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 3 inclusion and 5 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 12 Feb 2025. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hp eradication rate (time frame: 6 months). 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 12 Feb 2025.