Neoplasms

Digestive System Diseases

All Conditions

Infections

Symptoms and General Pathology

Rare Diseases

Stomach Neoplasms

Communicable Diseases

Gastritis

Helicobacter Infections

Disease Attributes

Gastrointestinal Diseases

Stomach Diseases

Bacterial Infections

Gram-Negative Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Gastroenteritis

Stomach Cancer

Anti-Infective Agents

All Drugs and Chemicals

Gastrointestinal Agents

Amoxicillin

Esomeprazole

Anti-Bacterial Agents

Antacids

Anti-Ulcer Agents

Proton Pump Inhibitors

Enzyme Inhibitors

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

Amoxicillin - high dose dual therapy

Pylera

Esomeprazole 40mg

Vítor Bruno Macedo Silva, M.D.

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.

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

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

Hospital da Senhora da Oliveira

Medical Doctor

Gastroesophageal Reflux

Esophagitis

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

The patients in this group were advised to take PPI for 8 weeks continuously, followed by on-demand PPI therapy for the following 40 weeks.

The patients in this group were advised to take PPI QD continuously for 48 weeks.

SUNG-SHUO KAO, Bachelor

On-demand PPI therapy is feasible for the long-term treatment of patients with Barrett's esophagus.

Consecutive patients with symptomatic Barrett's esophagus are recruited and receive biopsy for esophageal metaplastic mucosa and gastric mucosa over the antrum and body during endoscopy on enrollment. The biopsy protocol for esophageal metaplastic mucosa is following Seattle protocol. GERD Q score will be conducted on enrollment. Additionally, blood sampling for CYP2C19 genotyping is also conducted on enrollment. The eligible subjects will be treated by 8-week esomeprazole, and are then randomly assigned to receive either maintenance or on-demand esomeprazole therapy (40 mg q.d.) for 40 weeks. The patients were asked to come back every four weeks for the recording of symptom days and PPI tablet consumption numbers. Follow-up endoscopy with biopsy for esophageal and gastric mucosa is performed at the end of the 48th weeks. We will compare the effects of maintenance and on-demand PPI therapy on (1) histological changes of esophageal metaplastic mucosa (2) symptom control (3) tablet consumption number

On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.

The Impacts of On-demand Versus Continuous Esomeprazole Therapy on the Symptom Control and Histological Changes of Metaplastic Esophageal Epithelium in Patients With Barrett's Esophagus (EsoBE) - a Multicentre Randomized Controlled Trial

Kaohsiung Veterans General Hospital.

Principal Investigator

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Comparison Between High-dose Amoxicillin Dual Therapy and Pylera Quadruple Therapy in the Treatment of Helicobacter Pylori Infection	NCT05100446	Helicobacter Py... Gastritis Gastric Cancer	Amoxicillin - h... Pylera Esomeprazole 40...	18 Years - 75 Years	Hospital da Senhora da Oliveira
On-demand PPI Therapy is Effective on Controlling Symptoms in Patients With Barrett's Esophagus.	NCT04329000	Barrett Esophag... Proton Pump Inh... Symptom Reflux	Esomeprazole 40... Esomeprazole	20 Years - 80 Years	Kaohsiung Veterans General Hospital.

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