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Intraluminal Therapy for Helicobacter Pylori Infection

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ClinicalTrials.gov Identifier: NCT03124420
Recruitment Status : Completed
First Posted : April 21, 2017
Last Update Posted : May 2, 2018
Sponsor:
Information provided by (Responsible Party):
Tai-cherng Liou, MD, Mackay Memorial Hospital

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 improve the eradication rate of H. pylori infection while an endoscopic examination is performed.


Condition or disease Intervention/treatment Phase
Helicobacter Pylori Infection Drug: Lansoprazole Drug: Amoxicillin Drug: 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. 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Group A: 7-day triple therapy for patients fail to achieve intraluminal eradication Group B: 14-day triple therapy for patients fail to achieve intraluminal eradication
Masking: Single (Investigator)
Masking Description: open labeled, randomized control trial.
Primary Purpose: Treatment
Official Title: Intraluminal Therapy for Helicobacter Pylori Infection
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: 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 Name: 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 Name: 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 Name: 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 Name: Klaricid




Primary Outcome Measures :
  1. Eradication rate in the intraluminal therapy [ Time Frame: 6 weeks after finishing therapy ]
    C13-UBT will be used to assess the existence of H. pylori 6 weeks after the intraluminal therapy


Secondary Outcome Measures :
  1. Eradication rates in the two groups of rescue oral antibiotics therapies. [ Time Frame: 6 weeks after finishing therapy ]
    C13-UBT will be used to assess the existence of H. pylori 6 weeks after finishing rescue oral antibiotics therapies.

  2. 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. 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. Short term recurrent rate [ Time Frame: 3-6 months after intraluminal therapy. ]

    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 .


  4. 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


Other Outcome Measures:
  1. Evaluate eradication outcome of intraluminal therapy [ Time Frame: 6 weeks after finishing therapy ]
    Evaluate eradication outcome by endoscopy urease test, the pH value of gastric juice or urea breath test



Information from the National Library of Medicine

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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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03124420


Locations
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Taiwan
Division of Gastroenterology and Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan
Taipei, Taiwan, 10449
Sponsors and Collaborators
Mackay Memorial Hospital
Investigators
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Principal Investigator: Tai-cherng Liou, MD Division of Gastroenterology, Department of Internal Medicine, Mackay Memorial Hospital, Taipei, Taiwan

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Tai-cherng Liou, MD, Clinical associate professor, Department of Medicine, Mackay Medical College, New Taipei City, Taiwan, Mackay Memorial Hospital
ClinicalTrials.gov Identifier: NCT03124420     History of Changes
Other Study ID Numbers: 17MMHIS020
First Posted: April 21, 2017    Key Record Dates
Last Update Posted: May 2, 2018
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Tai-cherng Liou, MD, Mackay Memorial Hospital:
Helicobacter Infection
Eradication therapy
Antibiotics
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Anti-Bacterial Agents
Amoxicillin
Clarithromycin
Lansoprazole
Dexlansoprazole
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors