EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS

Study Overview
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Brief Summary
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This is a prospective, randomized, double - blind study of 200 male and female volunteers with gastritis diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from October 2019 to July 2020. . Hypothesis: As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolius raddi), associated with amoxicillin and clarithromycin, for the treatment of patients diagnosed with gastritis and dyspeptic symptoms has similar efficacy and safety (non-inferior) and/or superior efficacy and safety to traditional therapy based on the use of omeprazole-associated antibiotic therapy.

Detailed Description
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This is a prospective, randomized, double - blind study of 200 male and female volunteers with gastritis diagnosed at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic from October 2019 to July 2020. . Hypothesis: As a non-inferiority study, the hypothesis is that the use of oral Aroeira (Schinus terebinthifolius raddi), associated with amoxicillin and clarithromycin, for the treatment of patients diagnosed with gastritis and dyspeptic symptoms has similar efficacy and safety (non-inferior) and/or superior efficacy and safety to traditional therapy based on the use of omeprazole-associated antibiotic therapy. Phase 3, double-blind, randomized, unicenter, clinical trial for patients who are diagnosed with H pylori gastritis and have associated dyspeptic symptoms seen at the Oswaldo Cruz University Hospital Gastroenterology Outpatient Clinic in Recife / PE, Brazil. October 2019 to July 2020. In order to verify the hypothesis that treatment with oral Aroeira, amoxicillin and clarithromycin has similar (not inferior) and/or superior efficacy and safety than treatment with omeprazole, amoxicillin and clarithromycin, a sample of 200 patients was defined, keeping the proportion 1: 1, which will be divided into two groups: Test group with 100 patients undergoing treatment with: oral Aroeira (Schinus terebinthifolius Raddi, 640mg / tablet) 1 tablet every 12 hours + amoxicillin 2 500mg tablets every 12 hours + clarithromycin 1 tablet 500mg every 12 hours for 14 days. Control group with 100 patients undergoing treatment with: omeprazole 1 20mg tablet every 12 hours + amoxicillin 2 500mg tablet every 12 hours + clarithromycin 1 tablet 500mg every 12 hours for 14 days. At the beginning of the study, patients will answer the sociodemographic questionnaire, which includes identification data, concomitant presence of chronic diseases and time of onset of symptoms. Patients will also respond to the symptom questionnaire. At the time of upper digestive endoscopy and pathological examination, which will be performed before and after treatment completion, patients will have their results graded endoscopically, using the Sydney criteria and according to the Sydney Histological Classification. After performing the second upper digestive endoscopy and pathological examination, professionals will be instructed to answer questionnaires to evaluate the endoscopic and histological response to treatment. At the end of treatment, patients will respond to a specific treatment response questionnaire.

Official Title
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EFFICACY OF ORAL AROEIRA (Schinus Terebinthifolius Raddi), AMOXYCILLIN AND CLARITROMYCIN COMPARED WITH CONVENTIONAL TRIPLE THERAPY FOR Helicobacter Pylori ERADICATION IN GASTRITE AND SYMPTOM PATIENTS: A RANDOMIZED AND DOUBLE-BLIND STUDY

Conditions
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Gastritis, Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Oral Aroeira/ Amoxicillin/ Claritromycin
* Drug: Omeprazole/ Amoxicillin/ Claritromycin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients who: Report dyspeptic symptoms (nausea, heartburn, epigastric pain, aggravated / relieved abdominal discomfort, and early satiety); Confirmação Have gastritis and H pylori confirmed by upper digestive endoscopy and pathological examination; are between 18 and 80 years old; Understand and sign the Informed Consent Form. Exclusion criteria: Patients who: Are being treated with proton pump inhibitor, non-steroidal anti-inflammatory drugs and / or H2 receptor blockers in the month prior to enrollment for clinical study. Are pregnant or lactating. Have intestinal obstruction, gastrointestinal surgery in the last thirty days, *Barrett's esophagus. * Make use of reflux stimulating drugs. With Zollinger-Ellison Syndrome, * Have active bleeding. Are currently in use or have recently used oral / venous antibiotics (within the last six weeks). Patients whose biopsy from upper digestive endoscopy is negative for H. pylori will also be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treated Group<br>in which dry Aroeira extract (Schinus terebinthifolius raddi, 640mg / tablet) will be administered + amoxicillin 500mg 2 tablets + clarithromycin, 500mg 1 tablet given twice daily (12/12 hours). | Drug: Oral Aroeira/ Amoxicillin/ Claritromycin<br>* Oral Aroeira (Schinus terebinthifolius Raddi, 640mg/tablet) 1 tablet, twice day, 12/12 hours + Amoxicillin 2 tablets of 500mg, twice day, 12/12 hours, + Claritromycin, 1 tablet of 500mg, twice day, 12/12 hours, for 14 days.<br>|
| Active Comparator: Control Group<br>in which 1 tablet of 20mg of omeprazole will be administered + amoxicillin 2 tablets of 500mg + clarithromycin, 1 tablet of 500mg administered twice daily (12/12 hours). | Drug: Omeprazole/ Amoxicillin/ Claritromycin<br>* Omeprazole 1 tablet of 20mg, twice day, 12/12 hours + Amoxicillin 2 tablets of 500mg, twice day, 12/12 hours, + Claritromycin, 1 tablet of 500mg, twice day, 12/12 hours, for 14 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Definitive Cure | Definitive Cure: H. pylori eradication, determined by a score = 0, in relation to the quantitative presence of H. pylori (determined by the sum of antrum, angular notch, and body scores). | 60 days after the first day treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Parcial Cure | Partial Healing: Quantitative reduction in relation to the presence of H. pylori (determined by the sum of the antrum, angular notch and body scores), but without eradication. | 60 days after the first day treatment | 
| Clinical Failure | Clinical Failure: no response to treatment, determined by maintenance or quantitative worsening of H. pylori presence (determined by sum of antrum, angular notch, and body scores) | 60 days after the first day treatment |