Intraluminal Clarithromycin Powder Monotherapy for Helicobacter Pylori Infection

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 Clarithromycin powder in the Intraluminal therapy for Helicobacter pylori infection while an endoscopic examination is performed.

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Clarithromycin; Drug: Amoxicillin, 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. 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 Clarithromycin powder (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. 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 triple therapy which contains a proton pump inhibitor and two antibiotics ( amoxicillin and clarithromycin) 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

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: 18 years to 73 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 Clarithromycin, Amoxicillin, 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: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Intraluminal Clarithromycin eradication; 20 Patients receive intraluminal Clarithromycin eradication of H. pylori.	Drug: Clarithromycin; Twenty patients receive intraluminal clarithromycin eradication of H. pylor.; Other Names: Klaricid
Other: Oral standard triple therapy; Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with triple therapy which contains a proton pump inhibitor and two antibiotics ( amoxicillin, and clarithromycin) for 14 days.	Drug: Amoxicillin, Clarithromycin; Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with triple therapy which contains a proton pump inhibitor, amoxicillin and clarithromycin for 14 days.; Other Names: Supercillin, Klaricid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Eradication rate in the intraluminal 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	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.	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

• Sponsor: Mackay Memorial Hospital
• Investigators: Principal Investigator: Tai-cherng Liou, MD, Mackay Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2018
• Primary Completion (Actual): December 28, 2018
• Study Completion (Actual): February 8, 2019

Study Registration Dates

• First Submitted: April 23, 2018
• First Submitted That Met QC Criteria: May 3, 2018
• First Posted (Actual): May 4, 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: Lansoprazole, Amoxicillin, clarithromycin
• Additional Relevant MeSH Terms: Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Amoxicillin; Clarithromycin
• Other Study ID Numbers: 17MMHIS097

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No