Intraluminal Amoxicillin Powder Monotherapy for Helicobacter Pylori Infection

February 12, 2019 updated by: Tai-cherng Liou, MD, Mackay Memorial Hospital

Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan

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 evaluate the efficacy of Amoxicillin powder in the Intraluminal therapy for Helicobacter pylori infection while an endoscopic examination is performed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. Patients will receive test for UFT300 to evaluate H. pylori colonization in the gastric cardia. 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 Amoxicillin powder in the capsule (3 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. C13-Urea breath test (UBT) will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy. Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with High-dose PPI-amoxicillin dual therapy (rabeprazole 20 mg and amoxicillin 750 mg 4 times/day) for 14 days. C13-UBT will be used to assess the existence of H. pylori 6 weeks after the rescue therapy. Overall eradication rates after the first line intraluminal therapy and the oral antibiotics rescue therapies will be evaluated.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • 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 Locations

  • Taiwan
      • Taipei, Taiwan, 10449
        • Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan

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

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients aged greater than 20 years and less than 75 years
  2. Patients have H. pylori infection without prior eradication therapy
  3. Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.

Exclusion Criteria:

  1. Children and teenagers aged less than 20 years, and adult greater than 75 years
  2. Contraindication for endoscopic examination or food retention in the gastric lumen.
  3. History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction; Gastroduodenal malignancy, including adenocarcinoma and lymphoma
  4. Contraindication to treatment drugs: previous allergic reaction to amoxicillin, Proton pump inhibitors (lansoprazole, rabeprazole), Acetylcystein and Sucralfate; pregnant or lactating women
  5. Severe concurrent acute or chronic illness: renal failure, cirrhosis of liver, incurable malignant disease
  6. Patients who cannot give informed consent by himself or herself.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Intraluminal Amoxicillin eradication
20 Patients receive intraluminal Amoxicillin eradication of H. pylori.
Drug: Amoxicillin
Twenty patients receive Intraluminal Amoxicillin eradication for H. pylori.
Other Names:
  • Supercillin
Other: Rabeprazole, Amoxicillin dual therapy
Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with high dose dual therapy (Rabeprazole and Amoxicillin) for 14 days.
Drug: Rabeprazole, Amoxicillin
Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with high dose dual therapy (Rabeprazole, Amoxicillin) for 14 days.
Other Names:
  • Pariet, Supercillin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication rate in the intraluminal therapy
Time Frame: 6 weeks after finishing therapy
Eradication rate in the intraluminal therapy C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy.
6 weeks after finishing therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall eradication rates
Time Frame: 3-6 months after finishing intraluminal therapy
Overall eradication rates after the first line intraluminal therapy and the oral antibiotics rescue therapies.
3-6 months after finishing intraluminal therapy

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse effects in the intraluminal therapy.
Time Frame: within 7 days after finishing the intraluminal therapy
Incidence of adverse effects were evaluated for Participants who had or had not finished the intraluminal therapy.
within 7 days after finishing the intraluminal therapy

Collaborators and Investigators

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

Sponsor

Mackay Memorial Hospital

Investigators

  • Principal Investigator: Tai-cherng Liou, MD, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital

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)

May 11, 2018

Primary Completion (Actual)

February 12, 2019

Study Completion (Actual)

February 12, 2019

Study Registration Dates

First Submitted

April 22, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (Actual)

May 11, 2018

Study Record Updates

Last Update Posted (Actual)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17MMHIS096

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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