Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection
Primary Purpose
Helicobacter Pylori Infection, Gastritis, Gastric Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
Portugal
Study Type
Interventional
Intervention
Amoxicillin - high dose dual therapy
Pylera
Esomeprazole 40mg
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
Eligibility Criteria
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
Sites / Locations
- Vítor Bruno Macedo da SilvaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Treatment with Pylera (r) + esomeprazole 40mg
Treatment with high-dose amoxicillin + esomeprazole 40mg
Arm Description
Outcomes
Primary Outcome Measures
Helicobacter pylori eradication
Confirmation of H. pylori eradication
Secondary Outcome Measures
Full Information
NCT ID
NCT05100446
First Posted
October 19, 2021
Last Updated
October 28, 2021
Sponsor
Hospital da Senhora da Oliveira
1. Study Identification
Unique Protocol Identification Number
NCT05100446
Brief Title
Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection
Official Title
Prospective Randomized Trial: Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital da Senhora da Oliveira
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection, Gastritis, Gastric Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Pylera (r) + esomeprazole 40mg
Arm Type
Active Comparator
Arm Title
Treatment with high-dose amoxicillin + esomeprazole 40mg
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Amoxicillin - high dose dual therapy
Intervention Description
Eradication with Amoxicillin 1000mg + 500 mg + 1000mg + 500mg, for 15 days.
Intervention Type
Drug
Intervention Name(s)
Pylera
Intervention Description
Eradication with Pylera, for 10 days.
Intervention Type
Drug
Intervention Name(s)
Esomeprazole 40mg
Intervention Description
Esomeprazole 40mg, twice a day.
Primary Outcome Measure Information:
Title
Helicobacter pylori eradication
Description
Confirmation of H. pylori eradication
Time Frame
Approximately 1 month after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Vítor Bruno Macedo da Silva
City
Guimarães
ZIP/Postal Code
4835-044
Country
Portugal
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vítor Bruno Macedo Silva, M.D.
Phone
00351253540330
Email
vitorbmacedo@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection
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