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NCT05957432
Efficacy and Safety of Black Seed Oil With Vonoprazan Based Triple Therapy in Treatment of Helicobacter Pylori
Conditions: Helicobacter Pylori Infection
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 90
Sponsor: Ain Shams University
Location: GIT department zagazig university hospital Zagazig
Summary
The aim of this study is to:
• Evaluation of efficacy and safety of adding black seed oil with vonoprazan triple therapy ( vonoprazan ,clarithromycin and amoxicillin ) in eradication of Helicobacter pylori infection and this will be done through evaluation of:
A. Efficacy by:
1. determination of successful eradication,which will be considered to be achieved on the basis of a negative stool antigen test four weeks after the end of treatment using Stool Ag test
2. The effect of N. Sativa on:
I. Oxidative stress by measuring MDA II. Inflammation by measuring IL1B as inflammatory markers
B. Safety will be done through:
Monitoring of expected treatment related adverse effects (black seed oil and vonoprazan triple therapy ) will be done through the whole study period.
C. Symptoms evaluation using the Gastrointestinal symptom rating scale D. Assessment of patient's quality of life using SF36 questionnaire
Eligibility Criteria
Inclusion Criteria:
* Male or female patients
* Age 18 to 75 years old
* Patients with confirmed H. pylori infection by stool Ag test who had not received prior eradication therapy
Exclusion Criteria:
* History of hypersensitivity / allergy to any of the study drugs i.e., Esomeprazole, vonoprazan, penicillin, or clarithromycin
* History of previous H. pylori eradication therapy
* History of using PPIs, antibiotics that affect H. pylori within 4 weeks
* History of gastric malignancy or surgery
* Serious cardiovascular, pulmonary, renal, hepatic disorders or active malignancy
* Pregnancy or breast feeding
* History of drug abuse or active alcohol abuse
Source: ClinicalTrials.gov (NCT05957432). StuddyBuddy aggregates publicly available trial information.