Efficacy and Safety of Black Seed Oil With Vonoprazan Based Triple Therapy in Treatment of Helicobacter Pylori

NCT05957432 | Active Not Recruiting Phase 2

• 1 other identifier: Black seed oil with Vonoprazan
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to:

1. 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. 2.The effect of N. Sativa on:

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infection; vonoprazan; black seed oil; oxidative stress

Outcome Measures

Primary Outcomes (2)

• Stool antigen test at baseline ( pre-intervention)

  Stool Antigen Test: The test is qualitative and is based on the detection of H. pylori antigen in human feces ( positive test )

  at baseline for diagnosis of helicobacter pylori (before start of triple therapy )

• Change of Stool antigen test after 4 weeks from triple therapy

  evaluate successful eradication of helicobacter pylori by negative stool Ag test

  after 4 weeks from triple therapy

Secondary Outcomes (5)

• Change in MDA (oxidative stress marker) levels

  change from baseline at 6 weeks

• Change in Interleukin 1B ( inflammatory markers ) levels

  change from baseline at 6 weeks

• "Gastrointestinal symptom rating scale"

  change from baseline at 6 weeks

• SF36 questionnaire

  change from baseline at 6 weeks

• Safety and tolerability

  every week for 4 weeks

Study Arms (2)

Group 1 , Black seed oil group

ACTIVE COMPARATOR

45 patients will receive they will receive 1800 mg (4 soft gelatin capsules of 450 mg) black seed oil (2 capsules twice daily 30 min after the meal) for 6 weeks plus vonoprazan-based triple therapy ( conventional therapy ) consists of vonoprazan 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1000 mg twice daily for 14 days

Drug: Black Seed Oil Cap/Tab; Drug: Vonoprazan, Amoxicillin and Clarithromycin

Group 2 , control group

ACTIVE COMPARATOR

This group consists of 45 patients, who will receive vonoprazan-based triple therapy(conventional therapy ) consists of vonoprazan 20 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1000 mg twice daily for 14 days

Drug: Vonoprazan, Amoxicillin and Clarithromycin

Interventions

Black Seed Oil Cap/Tab DRUG

possessed anti-H. pylori activity comparable to triple therapy and improved dyspepsia symptoms in infected patients

Also known as: Baraka 450 mg

Group 1 , Black seed oil group

Vonoprazan, Amoxicillin and Clarithromycin DRUG

H pylori vonoprazan based treatment

Group 1 , Black seed oil group; Group 2 , control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

GIT department zagazig university hospital

Zagazig, Egypt

Location

Related Publications (12)

• Sjomina O, Pavlova J, Niv Y, Leja M. Epidemiology of Helicobacter pylori infection. Helicobacter. 2018 Sep;23 Suppl 1:e12514. doi: 10.1111/hel.12514.

  PMID: 30203587 RESULT

• Wagner S, Varrentrapp M, Haruma K, Lange P, Muller MJ, Schorn T, Soudah B, Bar W, Gebel M. The role of omeprazole (40 mg) in the treatment of gastric Helicobacter pylori infection. Z Gastroenterol. 1991 Nov;29(11):595-8.

  PMID: 1771934 RESULT

• Chey WD, Wong BC; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007 Aug;102(8):1808-25. doi: 10.1111/j.1572-0241.2007.01393.x. Epub 2007 Jun 29.

  PMID: 17608775 RESULT

• Suzuki S, Gotoda T, Kusano C, Iwatsuka K, Moriyama M. The Efficacy and Tolerability of a Triple Therapy Containing a Potassium-Competitive Acid Blocker Compared With a 7-Day PPI-Based Low-Dose Clarithromycin Triple Therapy. Am J Gastroenterol. 2016 Jul;111(7):949-56. doi: 10.1038/ajg.2016.182. Epub 2016 May 17.

  PMID: 27185079 RESULT

• Jung YS, Kim EH, Park CH. Systematic review with meta-analysis: the efficacy of vonoprazan-based triple therapy on Helicobacter pylori eradication. Aliment Pharmacol Ther. 2017 Jul;46(2):106-114. doi: 10.1111/apt.14130. Epub 2017 May 12.

  PMID: 28497487 RESULT

• Hashem-Dabaghian F, Agah S, Taghavi-Shirazi M, Ghobadi A. Combination of Nigella sativa and Honey in Eradication of Gastric Helicobacter pylori Infection. Iran Red Crescent Med J. 2016 Jun 21;18(11):e23771. doi: 10.5812/ircmj.23771. eCollection 2016 Nov.

  PMID: 28191328 RESULT

• Salem EM, Yar T, Bamosa AO, Al-Quorain A, Yasawy MI, Alsulaiman RM, Randhawa MA. Comparative study of Nigella Sativa and triple therapy in eradication of Helicobacter Pylori in patients with non-ulcer dyspepsia. Saudi J Gastroenterol. 2010 Jul-Sep;16(3):207-14. doi: 10.4103/1319-3767.65201.

  PMID: 20616418 RESULT

• Augusto AC, Miguel F, Mendonca S, Pedrazzoli J Jr, Gurgueira SA. Oxidative stress expression status associated to Helicobacter pylori virulence in gastric diseases. Clin Biochem. 2007 Jun;40(9-10):615-22. doi: 10.1016/j.clinbiochem.2007.03.014. Epub 2007 Mar 28.

  PMID: 17466292 RESULT

• Alizadeh-Naini M, Yousefnejad H, Hejazi N. The beneficial health effects of Nigella sativa on Helicobacter pylori eradication, dyspepsia symptoms, and quality of life in infected patients: A pilot study. Phytother Res. 2020 Jun;34(6):1367-1376. doi: 10.1002/ptr.6610. Epub 2020 Jan 9.

  PMID: 31916648 RESULT

• Kato M, Ota H, Okuda M, Kikuchi S, Satoh K, Shimoyama T, Suzuki H, Handa O, Furuta T, Mabe K, Murakami K, Sugiyama T, Uemura N, Takahashi S. Guidelines for the management of Helicobacter pylori infection in Japan: 2016 Revised Edition. Helicobacter. 2019 Aug;24(4):e12597. doi: 10.1111/hel.12597. Epub 2019 May 20.

  PMID: 31111585 RESULT

• Kouitcheu Mabeku LB, Bello Epesse M, Fotsing S, Kamgang R, Tchidjo M. Stool Antigen Testing, a Reliable Noninvasive Method of Assessment of Helicobacter pylori Infection Among Patients with Gastro-duodenal Disorders in Cameroon. Dig Dis Sci. 2021 Feb;66(2):511-520. doi: 10.1007/s10620-020-06219-0. Epub 2020 Apr 30.

  PMID: 32350723 RESULT

• Veijola L, Myllyluoma E, Korpela R, Rautelin H. Stool antigen tests in the diagnosis of Helicobacter pylori infection before and after eradication therapy. World J Gastroenterol. 2005 Dec 14;11(46):7340-4. doi: 10.3748/wjg.v11.i46.7340.

  PMID: 16437639 RESULT

MeSH Terms

Interventions

1-(5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl)-N-methylmethanamine; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones

Study Officials

• sara M zaky, ass.prof

  faculty of pharmacy Ain shams university

  PRINCIPAL INVESTIGATOR

• yasser A Elnaggar, prof

  faculty of medicine zagazig university

  STUDY CHAIR

• sara F Mohamed, lecturer

  faculty of pharmacy Ainshams university

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical pharmacist

Study Record Dates

• First Submitted: June 16, 2023
• First Posted: July 24, 2023
• Study Start: August 15, 2023
• Primary Completion: October 1, 2025
• Study Completion: November 1, 2025
• Last Updated: January 29, 2025

Record last verified: 2025-01

Locations

EG (1)