Intraluminal Clarithromycin Powder Monotherapy for Helicobacter Pylori Infection

• ClinicalTrials.gov Identifier: NCT03516669
• Recruitment Status: Completed
• First Posted: May 4, 2018
• Last Update Posted: February 15, 2019
• Sponsor: Mackay Memorial Hospital
• Information provided by (Responsible Party): Tai-cherng Liou, MD, Mackay Memorial Hospital

Study Description

Brief 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. 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.

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori Infection	Drug: Clarithromycin; Drug: Amoxicillin, Clarithromycin	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Non-Randomized
• Intervention Model: Single Group Assignment
• Intervention Model Description: 20 participants receive intraluminal eradication of H. pylori. 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.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Visiting Staff, Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
• Actual Study Start Date: May 7, 2018
• Actual Primary Completion Date: December 28, 2018
• Actual Study Completion Date: February 8, 2019

Arms and Interventions

Arm	Intervention/treatment
Intraluminal Clarithromycin eradication; 20 Patients receive intraluminal Clarithromycin eradication of H. pylori.	Drug: Clarithromycin; Twenty patients receive intraluminal clarithromycin eradication of H. pylor.; Other Name: Klaricid
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 Name: Supercillin, Klaricid

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. 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

Other Outcome Measures:

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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.

Contacts and Locations

Locations

Taiwan

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

Taipei, Taiwan, 10449

Sponsors and Collaborators

Mackay Memorial Hospital

Investigators

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

More Information

• Responsible Party: Tai-cherng Liou, MD, Principle investigator, Mackay Memorial Hospital
• ClinicalTrials.gov Identifier: NCT03516669
• Other Study ID Numbers: 17MMHIS097
• First Posted: May 4, 2018
• Last Update Posted: February 15, 2019
• Last Verified: February 2019

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tai-cherng Liou, MD, Mackay Memorial Hospital:

Lansoprazole, Amoxicillin, clarithromycin

Additional relevant MeSH terms:

Infections; Helicobacter Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Amoxicillin; Clarithromycin; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors