Intraluminal Therapy for Helicobacter Pylori Infection

Helicobacter Pylori Infection Clinical Trial

Official title:

Intraluminal Therapy for Helicobacter Pylori Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03124420
• Other study ID #: 17MMHIS020
• Status: Completed
• Phase: Phase 4
• Start date: April 28, 2017
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2017
• Source: Mackay Memorial Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 30, 2018
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Lansoprazole
Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days
• Amoxicillin
Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days
• Clarithromycin
Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days

Locations

Country	Name	City	State
Taiwan	Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Mackay Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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
Secondary	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
Secondary	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.
Secondary	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