Intraluminal Metronidazole Powder Monotherapy for Helicobacter Pylori Infection

NCT03524833 | Completed Phase 4

• 1 other identifier: 17MMHIS098
• Study Type: interventional
• Target: 20
• 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 evaluate the efficacy of Metronidazole powder in the Intraluminal therapy for Helicobacter pylori infection while an endoscopic examination is performed.

Conditions

Helicobacter Pylori Infection

Keywords

Lansoprazole, Amoxicillin, Metronidazole

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 (1)

• Overall eradication rates

  3-6 months after finishing intraluminal therapy

Other Outcomes (1)

• Incidence of adverse effects in the intraluminal therapy.

  within 7 days after finishing the intraluminal therapy

Study Arms (2)

Intraluminal Metronidazole eradication

OTHER

Twenty patients receive intraluminal Metronidazole eradication of H. pylori.

Drug: Metronidazole

oral antibiotic triple therapy

OTHER

Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic triple therapy which contains Lansoprazole, Amoxicillin and Metronidazole for 14 days.

Drug: Lansoprazole, Amoxicillin, Metronidazole

Interventions

Metronidazole DRUG

Twenty patients receive intraluminal Metronidazole eradication of H. pylori.

Also known as: Flagyl

Intraluminal Metronidazole eradication

Lansoprazole, Amoxicillin, Metronidazole DRUG

Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic triple therapy which contains Lansoprazole, Amoxicillin and Metronidazole for 14 days.

Also known as: Takepron, Supercillin, Flagyl

oral antibiotic 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 Metronidazole, Amoxicillin, 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

MeSH Terms

Interventions

Metronidazole; Lansoprazole; Amoxicillin

Intervention Hierarchy (Ancestors)

Nitroimidazoles; Nitro Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle investigator

Model Details: 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 metronidazole) for 14 days.

Study Record Dates

• First Submitted: April 23, 2018
• First Posted: May 15, 2018
• Study Start: May 7, 2018
• Primary Completion: January 8, 2019
• Study Completion: February 8, 2019
• Last Updated: February 15, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)