drugset / Trial / NCT07810985
Bismuth Quadruple Therapy Versus Modified Bismuth Therapy for Helicobacter Pylori
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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.