ILTHPI - Comparison of Medicament Containing Tetracycline, Metronidazole, Bismuth Versus Amoxicillin, Metronidazole, Clarithromycin

NCT04853875 | Completed Phase 4

• 1 other identifier: 21MMHIS016e
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Helicobacter pylori (H. pylori) is a spiral shaped, microaerophilic, gram negative bacterium. The organism resides in the acid and mucous layer of the human gastric mucosa, adheres to and colonizes the mucosal surface of the stomach and the mucosal epithelium with gastric metaplasia of duodenal bulb. Many studies have shown that H. pylori is an important causal factor of chronic gastritis, peptic ulcer disease, gastric cancer and gastric lymphoma. Endoscopic examination is indicated to confirm the above diagnosis for patient with H. pylori infection. The eradication rate of standard triple therapy has fallen below 80% in many countries due to the worldwide increasing prevalence of antibiotic resistant strains. This is related to the special gastric milieu of H. pylori, which leads to a more difficult and complicated treatment for achieving a successful eradication rate than other bacteria. Several strategies have been proposed to increase the eradication rate in the first line therapy or as a rescue therapy. However, these rescue therapies will increase the side effects and costs of treatment, decrease the compliance of patients and increase the rate of worldwide antibiotic resistance steadily. The WHO has listed H. Pylori as one of 12 antibiotic-resistant bacteria that have the greatest threat to human health in Feb. 2017. Our previous studies suggested that the administration of single -dose therapeutic agents can achieve the eradication of H. pylori immediately while conducting the endoscopic examination. The eradication rate of intraluminal therapy for H. pylori infection (ILTHPI) is 53.7% (51/95), and control the intragastric pH above 4 prior to the ILTHPI can even reach a 72.0%(36/50) eradication rate of H. pylori. According to the recent Taiwan consensus for the treatment of H. pylori in 2017, the first line therapeutic regiment of H. pylori containing Amoxicillin, Clarithromycin, and Metronidazole if the rate of Clarithromycin resistance is below 15%, while the first line therapeutic regiment of H. pylori containing tetracycline, metronidazole, and bismuth subcitrate if the rate of Clarithromycin resistance is above 15%. We aimed to evaluate and compare the efficacy of medicament containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin for the Intraluminal therapy of Helicobacter pylori infection.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter Pylori; Proton pump inhibitor; Amoxicillin; Metronidazole; Bismuth; Tetracycline; Clarithromycin

Outcome Measures

Primary Outcomes (1)

• The eradication rates of intraluminal therapy

  To evaluate and compare the eradication rates of different medicaments for the Intraluminal Therapy for Helicobacter pylori Infection between Group A and Group B.

  C13-UBT will be used to assess the existence of H. pylori 2 weeks after the intraluminal therapy

Secondary Outcomes (3)

• The adverse events of intraluminal therapy

  Within one week after the Intraluminal Therapy for Helicobacter pylori Infection

• The eradication rates of oral antibiotic rescue therapies

  C13-UBT will be used to assess the existence of H. pylori 4 weeks after the oral antibiotics rescue therapy

• The adverse events of oral antibiotic rescue therapies

  Within one week after complete the oral antibiotics rescue therapy

Study Arms (2)

Group A (Tetracycline, Metronidazole, and Bismuth)

EXPERIMENTAL

Intraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Tetracycline 2g, Metronidazole 2g, and Bismuth subcitrate 480 mg

Drug: Tetracycline, Metronidazole, Bismuth subcitrate

Group B (Amoxicillin, Metronidazole, and Clarithromycin)

ACTIVE COMPARATOR

Intraluminal Therapy for Helicobacter pylori Infection - Single dose medicament containing Amoxicillin 3g, Metronidazole 2g, and Clarithromycin 1g

Drug: Amoxicillin, Metronidazole, Clarithromycin

Interventions

Tetracycline, Metronidazole, Bismuth subcitrate DRUG

52 participants (Group A) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Tetracycline, Metronidazole, and Bismuth subcitrate

Also known as: Bismuth Trioxide

Group A (Tetracycline, Metronidazole, and Bismuth)

Amoxicillin, Metronidazole, Clarithromycin DRUG

52 participants (Group B) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Amoxicillin, Metronidazole, and Clarithromycin

Also known as: Klaricid

Group B (Amoxicillin, Metronidazole, and Clarithromycin)

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 between 20 years and 75 years
• Patients have H. pylori infection and have not treated with oral antibiotics
• 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:

• Patients will be excluded from the study if any one of the following criteria is present:
• Children and teenagers aged less than 20 years, or 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 of study, PPI (Lansoprazole), Acetylcysteine and Sucralfate; pregnant or lactating women
• Severe concurrent acute or chronic illness: renal failure, decompensated 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, 10449, Taiwan

Location

MeSH Terms

Interventions

Tetracycline; Metronidazole; bismuth tripotassium dicitrate; bismuth oxide; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Nitroimidazoles; Nitro Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• Tai-cherng Liou, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: 104 participants are randomly assigned to receive intraluminal eradication of H. pylori. with medicaments containing Tetracycline, Metronidazole, and Bismuth versus Amoxicillin, Metronidazole, and Clarithromycin.

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 21, 2021
• Study Start: April 19, 2021
• Primary Completion: August 30, 2022
• Study Completion: December 16, 2022
• Last Updated: January 4, 2023

Record last verified: 2023-01

Locations

TW (1)