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

Gastric Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05100446
• Other study ID #: 101/2020
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: October 2021
• Source: Hospital da Senhora da Oliveira
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Documented Helicobacter pylori infection

• Age equal or greater to 18 years

• Recent (<6months) upper digestive endoscopy

• Ability to consent to participate in the study

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Gastric Cancer
• Gastritis
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections

Intervention

Drug:
• Amoxicillin - high dose dual therapy
Eradication with Amoxicillin 1000mg + 500 mg + 1000mg + 500mg, for 15 days.
• Pylera
Eradication with Pylera, for 10 days.
• Esomeprazole 40mg
Esomeprazole 40mg, twice a day.

Locations

Country	Name	City	State
Portugal	Vítor Bruno Macedo da Silva	Guimarães

Sponsors (1)

Lead Sponsor	Collaborator
Hospital da Senhora da Oliveira

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Helicobacter pylori eradication	Confirmation of H. pylori eradication	Approximately 1 month after treatment