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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gastritis; Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Oral Aroeira/ Amoxicillin/ Claritromycin; Drug: Omeprazole/ Amoxicillin/ Claritromycin

Detailed Description

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:

1. 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.

2. 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.

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: JAN CARLO MORAIS OLIVEIRA B DELORENZ, PhD; Phone Number: 11989780869; Email: jancarlo@hebron.com.br
• Study Contact Backup: Name: Haliny Magalhães, Pharm. B.; Email: haliny@hebron.com.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated Group; 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; 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.
Active Comparator: Control Group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Infan Industria Quimica Farmaceutica Nacional
• Collaborators: Hospital Universitário Oswaldo Cruz
• Investigators: Principal Investigator: Severino B Santos, PhD, Hospital Univeristário Oswaldo Cruz

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2021
• Primary Completion (Anticipated): July 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: August 20, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 6, 2020
• Last Update Submitted That Met QC Criteria: August 5, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Gastroenteritis; Gastritis; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Omeprazole
• Other Study ID Numbers: HB/F3-001/2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No