Bismuth Quadruple Therapy Versus Modified Bismuth Therapy for Helicobacter Pylori
Eradication of Helicobacter Pylori: A Comparative Randomized Controlled Trial of Bismuth Quadruple Therapy and Bismuth Add-on to Clarithromycin Triple Therapy
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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
Study Design: Open label randomized controlled trial (RCT). Period of study:From September 2023 to September 2025 Participants: Among patients attending Gastroenterology clinic in Tropical medicine and infectious diseases department-Tanta university;200 patients with a confirmed diagnosis of helicobacter pylori infection were enrolled and allocated randomly in 2 equal parallel treatment arms.
Sample Size Calculation:
The sample size was calculated using a free online clinical trial calculator (ClinCalc.com) based on effect sizes from previous studies. A recent study in KSA reported an eradication rate of 78.3% for bismuth-based quadruple therapy [1]. Conversely, other studies have reported eradication rates of 88-94% [2] and 91.5-97.3% [3] for bismuth-based triple therapy. At a 95% confidence interval (α-error = 0.05) and 80% statistical power (β-error = 0.2), the minimum required sample size was 146 patients, allocated equally (73 per arm) [4]. To account for an anticipated attrition rate of approximately 30% a total of 200 patients (100 per group) were recruited.
Randomization and Allocation:
To ensure unbiased group assignment and concealment of the allocation sequence, a computer-generated randomization scheme was implemented. Block randomization was performed using a block size of 4, with computer-generated random permutations within each block. To minimize the risk of predicting the allocation sequence, the block size was randomly varied using blocks of 4 and 6 and was not disclosed to the treating investigator. Each enrolled patient was assigned a unique numerical identifier. The complete list of patient identifiers was then sorted in ascending order according to the generated random values. Based on this sorted sequence, the first 100 patients were allocated to Group I (Bismuth add on triple therapy), while the remaining 100 patients were assigned to Group II (Bismuth quadruple therapy). To maintain allocation concealment, the randomization sequence was generated by an independent investigator who was not involved in patient enrollment or outcome assessment. Group assignments were placed in sequentially numbered, opaque, sealed envelopes, which were opened just before starting treatment and after the enrolling physician confirmed patient eligibility and obtained written his/her informed consent.
All patients in the study will be subjected to the following:
Full history taking. Complete clinical examination. Laboratory Investigations including: complete blood picture, liver function tests and renal function tests.
Abdominal ultrasound. Confirm ation of H.pylori infection with either: quantification of H. pylori antigen in stool by ELISA, r upper gastrointestinal endoscopic biopsy and histopathological examination.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
-
-
Algharbia
-
Tanta, Algharbia, Egypte
- Tanta University
-
-
Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patients aged ≥ 18 years.
- Confirmed diagnosis of H. pylori infection.
Exclusion Criteria:
- Pregnant or lactating women.
- Prior treatment for H. pylori infection.
- History of antibiotic or PPI use within the month preceding enrollment.
- History of hypersensitivity or allergic reaction to any of the study drugs.
- Presence of any contraindication to the study medications.
- Advanced chronic liver disease or renal disease.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Bismuth added on triple therapy
100 patients received oral triple therapy with add-on bismuth in the form of (Bismuth subcitrate 240 mg twice daily, Clarithromycin 500 mg twice daily, Amoxicillin 1gm twice daily, (PPI) Esomeprazole 40 mg twice daily for 2 weeks).
|
A 14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Clarithromycin (500 mg twice daily), Amoxicillin (1 g twice daily), and the proton pump inhibitor (PPI) Esomeprazole (40 mg twice daily).
Andere namen:
|
|
Actieve vergelijker: bismuth quadruple therapy
100 patients received 14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Doxycycline (100 mg twice daily), Metronidazole (500 mg three times daily), and Esomeprazole (40 mg twice daily).
|
14-day oral regimen comprising Bismuth subcitrate (240 mg twice daily), Doxycycline (100 mg twice daily), Metronidazole (500 mg three times daily), and Esomeprazole (40 mg twice daily).
Andere namen:
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
cure rate
Tijdsspanne: 4 weeks after the end of therapy
|
cure rate in the experimental arm compared with cure rate in the comparator arm
|
4 weeks after the end of therapy
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
adverse events
Tijdsspanne: throughout the14 days of therapy
|
adverse events of the two regimens in the two arms
|
throughout the14 days of therapy
|
Medewerkers en onderzoekers
Sponsor
Publicaties en nuttige links
Algemene publicaties
- 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
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
product vervaardigd in en geëxporteerd uit de V.S.
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .