Intraluminal Therapy for Helicobacter Pylori Infection

NCT03124420 | Completed Phase 4

• 1 other identifier: 17MMHIS020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Infection; Eradication therapy; Antibiotics

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Eradication rates in the two groups of rescue oral antibiotics therapies.

  6 weeks after finishing therapy

• Overall eradication rates

  3-6 months after finishing intraluminal therapy

• Short term recurrent rate

  3-6 months after intraluminal therapy.

• Incidence of adverse effects in the intraluminal therapy.

  within 7 days after finishing the intraluminal therapy

Other Outcomes (1)

• Evaluate eradication outcome of intraluminal therapy

  6 weeks after finishing therapy

Study Arms (2)

Group A (Drug: 7-day triple therapy)

ACTIVE COMPARATOR

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; Drug: Amoxicillin; Drug: Clarithromycin

Group B (Drug: 14-day triple therapy)

SHAM COMPARATOR

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; Drug: Amoxicillin; Drug: Clarithromycin

Interventions

Lansoprazole DRUG

Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days

Also known as: Takepron

Group A (Drug: 7-day triple therapy); Group B (Drug: 14-day triple therapy)

Amoxicillin DRUG

Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days

Also known as: Supercillin

Group A (Drug: 7-day triple therapy); Group B (Drug: 14-day triple therapy)

Clarithromycin DRUG

Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days

Also known as: Klaricid

Group A (Drug: 7-day triple therapy); Group B (Drug: 14-day triple therapy)

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged greater than 20 years and less than 75 years
• Patients have H. pylori infection without prior eradication therapy
• Patients are willing to receive the intraluminal therapy. The written informed consents will be obtained from all patients prior to enrollment.

You may not qualify if:

• Children and teenagers aged less than 20 years, and adult greater than 75 years
• Contraindication for endoscopic examination or food retention in the gastric lumen.
• History of gastrectomy; Gastroduodenal stenosis、deformity or obstruction; Gastroduodenal malignancy, including adenocarcinoma and lymphoma
• Contraindication to treatment drugs: previous allergic reaction to antibiotics (amoxicillin, clarithromycin, metronidazole), Proton pump inhibitors (lansoprazole), Acetylcystein and Sucralfate; pregnant or lactating women
• Severe concurrent acute or chronic illness: renal failure, cirrhosis of liver, incurable malignant disease
• Patients who cannot give informed consent by himself or herself.

Sponsors & Collaborators

• Mackay Memorial Hospital: lead

Study Sites (1)

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

Taipei, 10449, Taiwan

Location

Related Publications (2)

• 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.

  PMID: 32545856 DERIVED

• 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.

  PMID: 30734357 DERIVED

MeSH Terms

Conditions

Helicobacter Infections

Interventions

Lansoprazole; Amoxicillin; Clarithromycin

Condition Hierarchy (Ancestors)

Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Tai-cherng Liou, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: open labeled, randomized control trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical associate professor, Department of Medicine, Mackay Medical College, New Taipei City, Taiwan

Model Details: 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

Study Record Dates

• First Submitted: April 14, 2017
• First Posted: April 21, 2017
• Study Start: April 28, 2017
• Primary Completion: December 31, 2017
• Study Completion: April 30, 2018
• Last Updated: May 2, 2018

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)