Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection

NCT05100446 | Unknown Early Phase 1

• 1 other identifier: 101/2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Helicobacter pylori is a pathogenic bacteria transmitted from individual to individual, being scientifically recognized as an agent who causes persistent inflammatory activity on the gastric mucosa. This pathogen represents a Global Health problem, as shown in a systematic review by Hooi et al. Besides regional differences, more that half of the world population is expected to have already been infected by this bacteria. In Portugal, research studies estimate that more than 80% of the adult population has already contacted with H. pylori. H. pylori infection is associated with active chronic gastritis in every colonized patient, what may consequently lead to peptic ulcer disease, atrophic gastritis, gastric adenocarcinoma and mucosa-associated lymphoid tissue (MALT) lymphoma. For that reason, H. pylori infection is considered to be a disease, independently of the presence of gastrointestinal symptoms. Additionally, H. pylori has been classified as a confirmed carcinogen (class I) by the International Agency for Research, being responsible for carcinogenic pathways conducting to both gastric adenocarcinoma and lymphoma. This fact gains a particular relevance taking into account that gastric cancer is one of the most prevalent cancers worldwide. On other hand, more than 75% of the gastric cancers occur following H. pylori infection. Thus, H. pylori eradication constitutes an essential Public Health measurement, being inclusively considered a cost-effective method to decrease the gastric cancer burden, by promoting pre-malignant lesions regression, such as atrophic gastritis, and by delaying the disease progression in case of intestinal metaplasia or dysplasia. Maastricht V consensus is a document updated in 2016, including the major recommendations regarding H. pylori diagnosis, follow-up and treatment. It highlights the emergence of antibiotic resistances and how they must influence clinical practice, namely the choice of antibiotic regimens, as successful eradication has become less frequent with more prevalent antibiotic resistances. This is the case of clarithromycin and metronidazol, both currently recommended as first-line options by the Portuguese Society of Gastroenterology. In fact, a systematic review conducted in 2018, aiming to evaluate antibiotic resistances on the Portuguese population observed that clarithromycin, metronidazole and double resistance occurred in 42%, 25% and 20% of the individuals, respectively. Nowadays, Maastricht V guidelines recommend quadruple regimens containing bismuth, such as Pylera (r), as the first-line option in areas with significant double resistance to metronidazole and clarithromycin. Another option currently being investigated is the double therapy with amoxicillin in high doses and proton pump inhibitor. This has become a particularly attractive alternative due to its efficacy, good tolerability and significantly low resistance (\<1%) among the European population. The aim of this clinical trial is to compare both regimens - pylera (r) and high-dose amoxycillin - in H. pylori eradication, regarding their efficacy, tolerability and side effects, in order to asses viable therapeutic options in a population with progressively increasing resistances to alternative regimens currently recommended.

Conditions

Helicobacter Pylori Infection; Gastritis; Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori eradication

  Confirmation of H. pylori eradication

  Approximately 1 month after treatment

Study Arms (2)

Treatment with Pylera (r) + esomeprazole 40mg

ACTIVE COMPARATOR

Drug: Pylera; Drug: Esomeprazole 40mg

Treatment with high-dose amoxicillin + esomeprazole 40mg

ACTIVE COMPARATOR

Drug: Amoxicillin - high dose dual therapy; Drug: Esomeprazole 40mg

Interventions

Amoxicillin - high dose dual therapy DRUG

Eradication with Amoxicillin 1000mg + 500 mg + 1000mg + 500mg, for 15 days.

Treatment with high-dose amoxicillin + esomeprazole 40mg

Pylera DRUG

Eradication with Pylera, for 10 days.

Treatment with Pylera (r) + esomeprazole 40mg

Esomeprazole 40mg DRUG

Esomeprazole 40mg, twice a day.

Treatment with Pylera (r) + esomeprazole 40mg; Treatment with high-dose amoxicillin + esomeprazole 40mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Documented Helicobacter pylori infection
• Age equal or greater to 18 years
• Recent (\<6months) upper digestive endoscopy
• Ability to consent to participate in the study

You may not qualify if:

• Documented allergy to any of the available drugs
• Contraindications to any of the available drugs
• Antibiotics use for the last 4 weeks
• Previous gastric cancer
• Previous gastric surgery
• Pregnancy
• Breastfeeding

Sponsors & Collaborators

• Unidade Local de Saúde do Alto Ave, EPE: lead

Study Sites (1)

Vítor Bruno Macedo da Silva

Guimarães, 4835-044, Portugal

RECRUITING

MeSH Terms

Conditions

Gastritis; Stomach Neoplasms

Interventions

Amoxicillin; Esomeprazole

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: October 19, 2021
• First Posted: October 29, 2021
• Study Start: May 1, 2021
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2022
• Last Updated: October 29, 2021

Record last verified: 2021-10

Locations

PT (1)