Intraluminal Therapy for Helicobacter Pylori Infection

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.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin

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 Type: Interventional
• Enrollment (Actual): 100
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

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 antibiotics (amoxicillin, clarithromycin, metronidazole), Proton pump inhibitors (lansoprazole), 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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A (Drug: 7-day triple therapy); 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)	Drug: Lansoprazole; Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days; Other Names: Takepron; Drug: Amoxicillin; Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days; Other Names: Supercillin; Drug: Clarithromycin; Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days; Other Names: Klaricid
Sham Comparator: Group B (Drug: 14-day triple therapy); 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).	Drug: Lansoprazole; Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days; Other Names: Takepron; Drug: Amoxicillin; Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days; Other Names: Supercillin; Drug: Clarithromycin; Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days; Other Names: Klaricid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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.	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.	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 .	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	within 7 days after finishing the intraluminal therapy

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate eradication outcome of intraluminal therapy	Evaluate eradication outcome by endoscopy urease test, the pH value of gastric juice or urea breath test	6 weeks after finishing therapy

Collaborators and Investigators

• Sponsor: Mackay Memorial Hospital
• Investigators: Principal Investigator: Tai-cherng Liou, MD, Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan

Publications and helpful links

General 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.
• Liou 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 14, 2017
• First Submitted That Met QC Criteria: April 20, 2017
• First Posted (Actual): April 21, 2017

Study Record Updates

• Last Update Posted (Actual): May 2, 2018
• Last Update Submitted That Met QC Criteria: May 1, 2018
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Antibiotics; Eradication therapy; Helicobacter Infection
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Dexlansoprazole; Lansoprazole; Amoxicillin; Clarithromycin
• Other Study ID Numbers: 17MMHIS020

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
• product manufactured in and exported from the U.S.: No