Helicobacter Pylori InfectionPhase 4NCT03124420
Intraluminal Therapy for Helicobacter Pylori Infection
A Phase 4 study testing Lansoprazole, Amoxicillin and Clarithromycin in people with Helicobacter Pylori Infection, run by Mackay Memorial Hospital at 1 site in Taiwan.
Trial summary
Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans. The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown that H. 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?
- Lansoprazole, Amoxicillin and Clarithromycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Apr 2017to 30 Apr 2018
- 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 greater than 20 years and less than 75 years
- Patients have H. pylori infection without prior eradication therapy
- Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.
Who cannot join
- Children and teenagers aged less than 20 years, and 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 (amoxicillin, clarithromycin, metronidazole), Proton pump inhibitors (lansoprazole), Acetylcystein and Sucralfate; pregnant or lactating women
- Severe concurrent acute or chronic illness: renal failure, 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, Taiwan
Taipei, 10449
About this study
Helicobacter pylori (H. pylori) is the most common chronic bacterial infection in humans.
The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Several strategies have been proposed to overcome the declining eradication rate, including (1) extending the treatment duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The investigators aim to improve the eradication rate of H. pylori infection while an endoscopic examination is performed.
Read the detailed description
During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg (5mg/1ml/amp), 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. With endoscope apparatus, the gastric mucous is irrigated with acetylcysteine solution and the pH value of gastric juice will be measured with the pH test strips before irrigation and after irrigation. The investigators dispense medicaments containing three kinds of antibiotics powder (Amoxicillin 3 gm、Metronidazole 2 gm and Clarithromycin 1 gm) on the surface of gastric mucosa and duodenal mucosa of duodenal bulb as evenly as possible. 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. Patients will receive tests for serum Helicobacter pylori immunoglobulin G, liver function and renal function 3 to 7 days after the intraluminal therapy. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy. Stool H. pylori Antigen will be used to assess the short term recurrence of H. pylori 4-6 months after successful intraluminal therapy . Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard triple therapy for either 7 days (Group A) or 14 days (Group B). C13-UBT will be used to assess the existence of H. pylori 6 weeks after the rescue triple therapy. Overall eradication rates after the first line intraluminal therapy and the oral antibiotics rescue therapies will be evaluated.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Lansoprazole, Amoxicillin, Clarithromycin
- Keywords
- Helicobacter Infection, Eradication therapy, Antibiotics
- Medical subject headings
- Helicobacter Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LansoprazoleDrug
Also called Takepron
Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days
AmoxicillinDrug
Also called Supercillin
Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days
ClarithromycinDrug
Also called Klaricid
Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Group A (Drug: 7-day triple therapy) | Active comparator | Intervention : Drug: 7-day triple therapy. Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard 7-day triple therapy ( lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. for 7 days) Receives: Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin |
| Group B (Drug: 14-day triple therapy) | Sham comparator | Intervention : Drug: 14-day triple therapy. Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard 14-day triple therapy ( lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. for 14 days). Receives: Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eradication rate in the intraluminal therapy
C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy
Measured: 6 weeks after finishing therapy
Secondary outcomes (4)
Eradication rates in the two groups of rescue oral antibiotics therapies.
C13-UBT will be used to assess the existence of H. pylori 6 weeks after finishing rescue oral antibiotics therapies.
Measured: 6 weeks after finishing therapy
Overall eradication rates
Overall eradication rates after the first line intraluminal therapy and the oral antibiotics rescue therapies. Overall eradication rates after the first line intraluminal therapy and the oral antibiotics rescuOverall eradication rates after the first line intraluminal therapy and the oral antibiotics rescue therapies. e therapies.
Measured: 3-6 months after finishing intraluminal therapy
Short term recurrent rate
To assess the short term recurrent rate 3-6 months after successful intraluminal therapy.
Stool H. Pylori Ag will be used to assess the short term recurrence of H. pylori 3-6 months after successful intraluminal therapy .
Measured: 3-6 months after intraluminal therapy.
Incidence of adverse effects in the intraluminal therapy.
Incidence of adverse effects were evaluated for Participants who had or had not finished the intraluminal therapy
Measured: within 7 days after finishing the intraluminal 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 2017
- Study start28 Apr 2017
- Primary completion31 Dec 2017
- Study completion30 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Group A: 7-day triple therapy for patients fail to achieve intraluminal eradication Group B: 14-day triple therapy for patients fail to achieve intraluminal eradication
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 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, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03124420
- Sponsor's protocol ID
- 17MMHIS020
- Status last verified
- Apr 2017
- First submitted
- 14 Apr 2017
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang YC, Chen YP, Ho CY, Liu TW, Chu CH, Wang HY, Liou TC. The Impact of Gastric Juice pH on the Intraluminal Therapy for Helicobacter pylori Infection. J Clin Med. 2020 Jun 14;9(6):1852. doi: 10.3390/jcm9061852.
PubMed 32545856Liou TC, Liao PH, Lin YC, Chu CH, Shih SC. Intraluminal therapy for Helicobacter pylori infection. J Gastroenterol Hepatol. 2019 Aug;34(8):1337-1343. doi: 10.1111/jgh.14627. Epub 2019 Feb 25.
PubMed 30734357
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraluminal Therapy for Helicobacter Pylori Infection
- ClinicalTrials.gov ID
- NCT03124420
- Acronym / sponsor ID
- 17MMHIS020
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter Infection, Eradication therapy, Antibiotics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mackay Memorial HospitalUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 30 Apr 2018 (actual)
- First posted
- 21 Apr 2017 (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 the most common chronic bacterial infection in humans.
The prevalence of H. pylori is about 30~50% in the Western adult population. It is estimated that about 50% of people are infected with this bacterium in Taiwan. Many studies have shown that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. The World Health Organization classified H. pylori as a Group 1 carcinogen in 1994. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Several strategies have been proposed to overcome the declining eradication rate, including (1) extending the treatment duration of triple therapy to 14 days; (2) the use of bismuth quadruple therapy which contains bismuth, a proton pump inhibitor, and two antibiotics (usually metronidazole and tetracycline); (3) non-bismuth quadruple therapy (concomitant therapy) which contains a proton pump inhibitor and three antibiotics (usually amoxicillin, metronidazole, and clarithromycin); (4) sequential therapy which contains a proton pump inhibitor (PPI) plus amoxicillin for five days, followed by a PPI plus clarithromycin and tinidazole for another five days. The investigators aim to improve the eradication rate of H. pylori infection while an endoscopic examination is performed.
Detailed description
During the endoscopic examination, patient is sedated with intravenous Dormicum 5mg (5mg/1ml/amp), 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. With endoscope apparatus, the gastric mucous is irrigated with acetylcysteine solution and the pH value of gastric juice will be measured with the pH test strips before irrigation and after irrigation. The investigators dispense medicaments containing three kinds of antibiotics powder (Amoxicillin 3 gm、Metronidazole 2 gm and Clarithromycin 1 gm) on the surface of gastric mucosa and duodenal mucosa of duodenal bulb as evenly as possible. 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. Patients will receive tests for serum Helicobacter pylori immunoglobulin G, liver function and renal function 3 to 7 days after the intraluminal therapy. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy. Stool H. pylori Antigen will be used to assess the short term recurrence of H. pylori 4-6 months after successful intraluminal therapy . Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard triple therapy for either 7 days (Group A) or 14 days (Group B). C13-UBT will be used to assess the existence of H. pylori 6 weeks after the rescue triple therapy. Overall eradication rates after the first line intraluminal therapy and the oral antibiotics rescue therapies will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Group A: 7-day triple therapy for patients fail to achieve intraluminal eradication Group B: 14-day triple therapy for patients fail to achieve intraluminal eradication
| Arm | Type | Receives |
|---|---|---|
| Group A (Drug: 7-day triple therapy) | Active comparator | Drug: Lansoprazole, Drug: Amoxicillin, Drug: ClarithromycinIntervention : Drug: 7-day triple therapy. Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard 7-day triple therapy ( lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. for 7 days) |
| Group B (Drug: 14-day triple therapy) | Sham comparator | Drug: Lansoprazole, Drug: Amoxicillin, Drug: ClarithromycinIntervention : Drug: 14-day triple therapy. Patients fail to achieve intraluminal eradication of H. pylori will be randomly assigned to the oral antibiotics rescue therapies with standard 14-day triple therapy ( lansoprazole 30 mg b.i.d., amoxicillin 1 g b.i.d. and clarithromycin 500 mg b.i.d. for 14 days). |
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 greater than 20 years and less than 75 years
- Patients have H. pylori infection without prior eradication therapy
- Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.
Key exclusion criteria (6 listed)
- Children and teenagers aged less than 20 years, and 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 (amoxicillin, clarithromycin, metronidazole), Proton pump inhibitors (lansoprazole), Acetylcystein and Sucralfate; pregnant or lactating women
- Severe concurrent acute or chronic illness: renal failure, cirrhosis of liver, incurable malignant disease
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 |
|---|---|---|
| LansoprazoleAlso: TakepronGroup A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days | Drug | Group A (Drug: 7-day triple therapy), Group B (Drug: 14-day triple therapy) |
| AmoxicillinAlso: SupercillinGroup A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days | Drug | Group A (Drug: 7-day triple therapy), Group B (Drug: 14-day triple therapy) |
| ClarithromycinAlso: KlaricidGroup A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days | Drug | Group A (Drug: 7-day triple therapy), Group B (Drug: 14-day triple therapy) |
Primary outcome
Eradication rate in the intraluminal therapy
Time frame: 6 weeks after finishing therapy
C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy
4 secondary outcomes
Eradication rates in the two groups of rescue oral antibiotics therapies.
Time frame: 6 weeks after finishing therapy
Overall eradication rates
Time frame: 3-6 months after finishing intraluminal therapy
Short term recurrent rate
Time frame: 3-6 months after intraluminal therapy.
Incidence of adverse effects in the intraluminal therapy.
Time frame: within 7 days after finishing the intraluminal 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 2 May 2018.
- Derived from this study: PubMed 32545856Wang YC, Chen YP, Ho CY, Liu TW, Chu CH, Wang HY, Liou TC. The Impact of Gastric Juice pH on the Intraluminal Therapy for Helicobacter pylori Infection. J Clin Med. 2020 Jun 14;9(6):1852. doi: 10.3390/jcm9061852.
- Derived from this study: PubMed 30734357Liou TC, Liao PH, Lin YC, Chu CH, Shih SC. Intraluminal therapy for Helicobacter pylori infection. J Gastroenterol Hepatol. 2019 Aug;34(8):1337-1343. doi: 10.1111/jgh.14627. Epub 2019 Feb 25.
- 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.
Tai-cherng Liou, MD principal investigator
Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
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 Lansoprazole, Amoxicillin and 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 6 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 2 May 2018. 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. 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?
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?
Eradication rate in the intraluminal therapy (time frame: 6 weeks after finishing therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03124420, which also lists 2 linked publications.
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 2 May 2018.