Helicobacter Pylori InfectionPhase 4NCT04853875
ILTHPI - Comparison of Medicament Containing Tetracycline, Metronidazole, Bismuth Versus Amoxicillin, Metronidazole, Clarithromycin
A Phase 4 study testing Tetracycline, Metronidazole, Bismuth subcitrate and Amoxicillin, Metronidazole, Clarithromycin in people with Helicobacter Pylori Infection, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Helicobacter pylori (H. pylori) is a spiral shaped, microaerophilic, gram negative bacterium. The organism resides in the acid and mucous layer of the human gastric mucosa, adheres to and colonizes the mucosal surface of the stomach and the mucosal epithelium with gastric metaplasia of duodenal bulb. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Tetracycline, Metronidazole, Bismuth subcitrate and Amoxicillin, Metronidazole, Clarithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Apr 2021to 16 Dec 2022
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged between 20 years and 75 years
- Patients have H. pylori infection and have not treated with oral antibiotics
- Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.
Who cannot join
- Patients will be excluded from the study if any one of the following criteria is present:
- Children and teenagers aged less than 20 years, or adult greater than 75 years
- Contraindication for endoscopic examination or food retention in the gastric lumen
- History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction; Gastroduodenal malignancy, including adenocarcinoma and lymphoma
- Contraindication to treatment drugs: previous allergic reaction to antibiotics of study, PPI (Lansoprazole), Acetylcysteine and Sucralfate; pregnant or lactating women
- Severe concurrent acute or chronic illness: renal failure, decompensated cirrhosis of liver, incurable malignant disease
- Patients who cannot give informed consent by himself or herself
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital
Taipei, 10449
About this study
Official title: Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
Helicobacter pylori (H. pylori) is a spiral shaped, microaerophilic, gram negative bacterium. The organism resides in the acid and mucous layer of the human gastric mucosa, adheres to and colonizes the mucosal surface of the stomach and the mucosal epithelium with gastric metaplasia of duodenal bulb. Many studies have shown that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. The eradication rate of standard triple therapy has fallen below 80% in many countries due to the worldwide increasing prevalence of antibiotic resistant strains. This is related to the special gastric milieu of H. pylori, which leads to a more difficult and complicated treatment for achieving a successful eradication rate than other bacteria. Several strategies have been proposed to increase the eradication rate in the first line therapy or as a rescue therapy. However, these rescue therapies will increase the side effects and costs of treatment, decrease the compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The WHO has listed H. Pylori as one of 12 antibiotic-resistant bacteria that have the greatest threat to human health in Feb. 2017. Our previous studies suggested that the administration of single -dose therapeutic agents can achieve the eradication of H. pylori immediately while conducting the endoscopic examination. The eradication rate of intraluminal therapy for H. pylori infection (ILTHPI) is 53.7% (51/95), and control the intragastric pH above 4 prior to the ILTHPI can even reach a 72.0%(36/50) eradication rate of H. pylori.
According to the recent Taiwan consensus for the treatment of H. pylori in 2017, the first line therapeutic regiment of H. pylori containing Amoxicillin, Clarithromycin, and Metronidazole if the rate of Clarithromycin resistance is below 15%, while the first line therapeutic regiment of H. pylori containing tetracycline, metronidazole, and bismuth subcitrate if the rate of Clarithromycin resistance is above 15%. We aimed to evaluate and compare the efficacy of medicament containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin for the Intraluminal therapy of Helicobacter pylori infection.
Read the detailed description
During the endoscopic examination, patient is sedated with intravenous Midazolam 5mg and Fentanyl 0.05mg, the vital signs will be closely monitored by physiological monitor (PHILIPS SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected or if patient asks for termination. The pH value of gastric juice will be measured with the pH test strips. and the he gastric mucus is irrigated with acetylcysteine solution. The investigators randomly assigned medicaments containing different antibiotic powders either Tetracycline 2g, Metronidazole 2g, and Bismuth 480mg (Group A) or Amoxicillin 3g, Metronidazole 2g, and Clarithromycin 1g (Group B) to dispense on the surface of gastric mucosa and duodenal mucosa of duodenal bulb. After the intraluminal therapy, patients will rest for 30 to 60 minutes and go home if the effect of sedation subsided. Patients can take meal if no abdominal discomfort. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 2 weeks after the intraluminal therapy. Patients failed to achieve intraluminal eradication of H. pylori will be assigned to 7-day concomitant therapy (Group A) or 7-day bismuth quadruple therapy (Group B). The C13-UBT will be used to assess the existence of H. pylori 4 weeks after the oral antibiotic therapy. The overall eradication rates of the intraluminal therapy plus the oral antibiotics therapies will be evaluated.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Tetracycline, Metronidazole, Bismuth subcitrate, Amoxicillin, Metronidazole, Clarithromycin
- Keywords
- Helicobacter Pylori, Proton pump inhibitor, Amoxicillin, Metronidazole, Bismuth, Tetracycline, Clarithromycin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tetracycline, Metronidazole, Bismuth subcitrateDrug
Also called Bismuth Trioxide
52 participants (Group A) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Tetracycline, Metronidazole, and Bismuth subcitrate
Amoxicillin, Metronidazole, ClarithromycinDrug
Also called Klaricid
52 participants (Group B) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Amoxicillin, Metronidazole, and Clarithromycin
| Study group | Role | What they receive |
|---|---|---|
| Group A (Tetracycline, Metronidazole, and Bismuth) | Experimental | Intraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Tetracycline 2g, Metronidazole 2g, and Bismuth subcitrate 480 mg Receives: Drug: Tetracycline, Metronidazole, Bismuth subcitrate |
| Group B (Amoxicillin, Metronidazole, and Clarithromycin) | Active comparator | Intraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Amoxicillin 3g, Metronidazole 2g, and Clarithromycin 1g Receives: Drug: Amoxicillin, Metronidazole, Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The eradication rates of intraluminal therapy
To evaluate and compare the eradication rates of different medicaments for the Intraluminal Therapy for Helicobacter pylori Infection between Group A and Group B.
Measured: C13-UBT will be used to assess the existence of H. pylori 2 weeks after the intraluminal therapy
Secondary outcomes (3)
The adverse events of intraluminal therapy
of different medicaments for the Intraluminal Therapy for Helicobacter pylori Infection between Group A and Group B.
Measured: Within one week after the Intraluminal Therapy for Helicobacter pylori Infection
The eradication rates of oral antibiotic rescue therapies
To evaluate and compare the eradication rates of different oral antibiotic rescue therapies for failed Intraluminal Therapy between concomitant therapy ( Group A) and bismuth-based quadruple therapy (Group B)
Measured: C13-UBT will be used to assess the existence of H. pylori 4 weeks after the oral antibiotics rescue therapy
The adverse events of oral antibiotic rescue therapies
To evaluate and compare the adverse events of different oral antibiotic rescue therapies for failed Intraluminal Therapy between concomitant therapy ( Group A) and bismuth-based quadruple therapy (Group B)
Measured: Within one week after complete the oral antibiotics rescue therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start19 Apr 2021
- Primary completion30 Aug 2022
- Study completion16 Dec 2022
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 104 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin.
- Masking
- None (open label)
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mackay Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tai-cherng Liou, MD, Mackay Memorial Hospital
- Investigators
- Tai-cherng Liou, MD, Principal investigator, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04853875
- Sponsor's protocol ID
- 21MMHIS016e
- Status last verified
- Jan 2023
- First submitted
- 14 Apr 2021
- Last updated
- 4 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
- ClinicalTrials.gov ID
- NCT04853875
- Acronym / sponsor ID
- 21MMHIS016e
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Pylori, Proton pump inhibitor, Amoxicillin, Metronidazole, Bismuth, Tetracycline, Clarithromycin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 30 Aug 2022 (actual)
- Study completion
- 16 Dec 2022 (actual)
- First posted
- 21 Apr 2021 (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.
Helicobacter pylori (H. pylori) is a spiral shaped, microaerophilic, gram negative bacterium. The organism resides in the acid and mucous layer of the human gastric mucosa, adheres to and colonizes the mucosal surface of the stomach and the mucosal epithelium with gastric metaplasia of duodenal bulb. Many studies have shown that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. The eradication rate of standard triple therapy has fallen below 80% in many countries due to the worldwide increasing prevalence of antibiotic resistant strains. This is related to the special gastric milieu of H. pylori, which leads to a more difficult and complicated treatment for achieving a successful eradication rate than other bacteria. Several strategies have been proposed to increase the eradication rate in the first line therapy or as a rescue therapy. However, these rescue therapies will increase the side effects and costs of treatment, decrease the compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The WHO has listed H. Pylori as one of 12 antibiotic-resistant bacteria that have the greatest threat to human health in Feb. 2017. Our previous studies suggested that the administration of single -dose therapeutic agents can achieve the eradication of H. pylori immediately while conducting the endoscopic examination. The eradication rate of intraluminal therapy for H. pylori infection (ILTHPI) is 53.7% (51/95), and control the intragastric pH above 4 prior to the ILTHPI can even reach a 72.0%(36/50) eradication rate of H. pylori.
According to the recent Taiwan consensus for the treatment of H. pylori in 2017, the first line therapeutic regiment of H. pylori containing Amoxicillin, Clarithromycin, and Metronidazole if the rate of Clarithromycin resistance is below 15%, while the first line therapeutic regiment of H. pylori containing tetracycline, metronidazole, and bismuth subcitrate if the rate of Clarithromycin resistance is above 15%. We aimed to evaluate and compare the efficacy of medicament containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin for the Intraluminal therapy of Helicobacter pylori infection.
Detailed description
During the endoscopic examination, patient is sedated with intravenous Midazolam 5mg and Fentanyl 0.05mg, the vital signs will be closely monitored by physiological monitor (PHILIPS SureSigns VM6). The treatment will be terminated immediately if unstable vital sign detected or if patient asks for termination. The pH value of gastric juice will be measured with the pH test strips. and the he gastric mucus is irrigated with acetylcysteine solution. The investigators randomly assigned medicaments containing different antibiotic powders either Tetracycline 2g, Metronidazole 2g, and Bismuth 480mg (Group A) or Amoxicillin 3g, Metronidazole 2g, and Clarithromycin 1g (Group B) to dispense on the surface of gastric mucosa and duodenal mucosa of duodenal bulb. After the intraluminal therapy, patients will rest for 30 to 60 minutes and go home if the effect of sedation subsided. Patients can take meal if no abdominal discomfort. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 2 weeks after the intraluminal therapy. Patients failed to achieve intraluminal eradication of H. pylori will be assigned to 7-day concomitant therapy (Group A) or 7-day bismuth quadruple therapy (Group B). The C13-UBT will be used to assess the existence of H. pylori 4 weeks after the oral antibiotic therapy. The overall eradication rates of the intraluminal therapy plus the oral antibiotics therapies will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 104 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin.
| Arm | Type | Receives |
|---|---|---|
| Group A (Tetracycline, Metronidazole, and Bismuth) | Experimental | Drug: Tetracycline, Metronidazole, Bismuth subcitrateIntraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Tetracycline 2g, Metronidazole 2g, and Bismuth subcitrate 480 mg |
| Group B (Amoxicillin, Metronidazole, and Clarithromycin) | Active comparator | Drug: Amoxicillin, Metronidazole, ClarithromycinIntraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Amoxicillin 3g, Metronidazole 2g, and Clarithromycin 1g |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged between 20 years and 75 years
- Patients have H. pylori infection and have not treated with oral antibiotics
- Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.
Key exclusion criteria (7 listed)
- Patients will be excluded from the study if any one of the following criteria is present:
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 |
|---|---|---|
| Tetracycline, Metronidazole, Bismuth subcitrateAlso: Bismuth Trioxide52 participants (Group A) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Tetracycline, Metronidazole, and Bismuth subcitrate | Drug | Group A (Tetracycline, Metronidazole, and Bismuth) |
| Amoxicillin, Metronidazole, ClarithromycinAlso: Klaricid52 participants (Group B) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Amoxicillin, Metronidazole, and Clarithromycin | Drug | Group B (Amoxicillin, Metronidazole, and Clarithromycin) |
Primary outcome
The eradication rates of intraluminal therapy
Time frame: C13-UBT will be used to assess the existence of H. pylori 2 weeks after the intraluminal therapy
To evaluate and compare the eradication rates of different medicaments for the Intraluminal Therapy for Helicobacter pylori Infection between Group A and Group B.
3 secondary outcomes
The adverse events of intraluminal therapy
Time frame: Within one week after the Intraluminal Therapy for Helicobacter pylori Infection
The eradication rates of oral antibiotic rescue therapies
Time frame: C13-UBT will be used to assess the existence of H. pylori 4 weeks after the oral antibiotics rescue therapy
The adverse events of oral antibiotic rescue therapies
Time frame: Within one week after complete the oral antibiotics rescue therapy
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 4 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.
Tai-cherng Liou, MD principal investigator
Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital
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 Tetracycline, Metronidazole, Bismuth subcitrate and Amoxicillin, Metronidazole, Clarithromycin in people with Helicobacter Pylori Infection, run by Mackay Memorial 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 3 inclusion and 7 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 4 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 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. 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?
The eradication rates of intraluminal therapy (time frame: C13-UBT will be used to assess the existence of H. pylori 2 weeks after the intraluminal therapy). 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 Jan 2023.