drugset / Trial / NCT07810985

Bismuth Quadruple Therapy Versus Modified Bismuth Therapy for Helicobacter Pylori

NCT07810985 ↗

Phase 3 Completed 200 enrolled Reham Abdelkader Elkhouly
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of the study is to compare the efficacy of 2 different regimens of treatment of gastric bacteria (H pylori) these are: quadruple bismuth therapy and clarithromycin triple therapy with add-on bismuth, in eradicating H. pylori. The secondary objective of the study is detection of adverse effects and treatment compliance in both regimens.

Timeline

Start
2023-09-01
Primary completion
2025-09-01
Completion
2025-09-01

Publications

  • Background 1)Awuku YA, Simpong DL, Alhassan IK, Tuoyire DA, et al (2017): Prevalence of Helicobacter pylori infection among children living in a rural setting in subSaharan Africa. BMC Public Health.17:360 2) Alhammad M.A.a, El-Kady H.b, Hamed Y.c. (2019): Clarithromycin resistance and genetic pattern of Helicobacter pylori in a group of patients with peptic ulcer disease in Alexandria, Egypt. International Journal of scientific and technology research. 8, Issue 3,149-159 3) Alsohaibani F, Alquaiz M, Alkahtani K, et al (2020): Efficacy of a bismuth-based quadruple therapy regimen for Helicobacter pylori eradication in Saudi Arabia.Saudi Journal of Gastroenterology. 26-2 4) Chey W.D, Leontiadis G.I, Howden C.W, et al (2017): ACG Clinical Guideline: Treatment of Helicobacter pylori Infection. Am J Gastroenterol .112:212-238 5) Fagoonee, S and Pellicano, R. (2019): Helicobacter pylori: Molecular basis for colonization and survival in gastric environment and resistance to antibiotics. A short review. Infect. Dis. 51, 399-408 6)Georgopoulos.s and Papastergiou.v (2021):An update on current and advancing pharmacotherapy options for the treatment of H. pylori infection Expert Opinion on Pharmacotherapy .Volume 22- Issue 6. 7) Ghaith.D, Elzahry.M, Mostafa.G, et al (2016): Mutations affecting domain V of the 23S rRNA gene in Helicobacter pylori from Cairo, Egypt. J Chemother. 28(5):367-370 8) Isaeva, G.S and Fagoonee, S (2018): Biological properties and pathogenicity factors of Helicobacter pylori. Minerva Gastroenterol. Dietol. 64, 255-266 9).KaneS.P(2019):SampleSizeCalculatorClinCalc:https://clincalc.com/stats/samplesize.aspx. Updated July 24, 2019. Accessed July 16, 2023. 10) Liao J, Zheng Q, Liang X, et al (2013): Effect of fluoroquinolone resistance on 14-day levofloxacin triple and triple plus bismuth quadruple therapy. Helicobacter.18:373-377. 11) McNicholl A.G, Bordin D.s, Lucendo.A(2020): Combination of Bismuth and Standard Triple Therapy Eradicates Helicobacter pylori Infec

Drugs

EvaluationDrugModalityDoseRoute
Subject Amoxicillin Other / unclassified 1 g Oral
Subject Clarithromycin Small molecule 500 mg Oral
Comparator Doxycycline Small molecule 100 mg Oral
Comparator Metronidazole Small molecule 500 mg Oral
Background Bismuth subcitrate Unknown 240 mg Oral
Background Esomeprazole Small molecule 40 mg Oral

Indications

No indication recorded.