Efficacy of Different Acid Suppressors in Bismuth-containing Quadruple Therapy Against Helicobacter Pylori

NCT05301725 | Completed DMC

• 1 other identifier: 2022-SDU-QILU-G001
• Study Type: observational
• Target: 670
• Locations: 1 country
• Sites: 1

Brief Summary

Ａretrospective study was conducted to compare the efficacy, safety, and cost-effectiveness of traditional proton pump inhibitors (PPI ) and Potassium-competitive acid blockers ( P-CAB )for clarithromycin-based bismuth-containing quadruple therapy in the management of Helicobacter pylori eradication.

Conditions

Helicobacter Pylori; Eradication Rate

Keywords

Helicobacter pylori,eradication therapy

Outcome Measures

Primary Outcomes (3)

• Rate of eradication success

  Six weeks after completion of treatment, numbers of patients get H.pylori eradicated supported by negative 13C-UBT results will be investigated by an independent researcher. Then eradication rate in each group will be calculated by using intention-to-treat (ITT) analysis, modified intention to treat analysis (MITT) and per-protocol (PP) analysis. The ITT analysis includes all the patients who take at least one dose of the study medications. The MITT analysis is limited to patients who complete follow-up.The PP analysis is limited to patients who take over 90% of the study medications and complete follow-up.

  1 month

• Prevalence of adverse events

  At the follow-up, adverse events complained by patients will be recorded by an independent researcher, meanwhile CTCAE v5.0 was used to evaluate severity of adverse events.The prevalence of adverse events was compared between the two group

  1 month

• Number of participants with good compliance

  Compliance was evaluated by assessing the total pills patients have taken.Compliance was defined as good whenmore than 90% or less than 120% of the total pills were taken

  1 month

Study Arms (2)

PPI group

PPI regimen

Other: PPI regimen

P-CAB group

P-CAB regimen

Other: P-CAB regimen

Interventions

PPI regimen OTHER

All patients received PPI regimen( lansoprazole or esomeprazole,bismuth amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.

PPI group

P-CAB regimen OTHER

All patients received P-CAB regimen(vonoprazan,bismuth ,amoxicillin,clarithromycin for14 days). Demographic data,treatment regimens, outcomes of therapy, adherence to therapy and adverse event were retrieved.

P-CAB group

Eligibility Criteria

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

Study Population

helicobacter infection

You may qualify if:

• Participants aged 18-75 years with persistent H. pylori infection.
• Participants received clarithromycin-based bismuth-containing quadruple therapy.

You may not qualify if:

• Patients received rescue therapy
• Patients treated with PPI, P-CAB,bismuth and antibiotics in the previous 4 weeks
• Patients with gastorectomy
• Currently pregnant or lactating or other conditions unable to receive therapy
• Severe concomitant cardiovascular, respiratory, or endocrine diseases, clinically significant renal or hepatic disease, hematologic disorders and any other clinically significant medical condition that could increase risk
• Severe neurologic or psychiatric disorders
• Information incomplete

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Qilu hosipital

Jinan, Shandong, 250012, China

Location

Related Publications (1)

• Wang J, Li YY, Lin MJ, Liu J, Lin BS, Ding YM, Wan M, Zhang WL, Kong QZ, Wang ST, Mu YJ, Duan M, Han ZX, Zuo XL, Li YQ. Vonoprazan is noninferior to proton pump inhibitors in bismuth-containing quadruple therapy for the treatment of Helicobacter pylori infection: A propensity score matching analysis. J Dig Dis. 2023 Jan;24(1):19-27. doi: 10.1111/1751-2980.13166. Epub 2023 Apr 22.

  PMID: 36960538 DERIVED

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Qilu Hospital gastroenterology department

Study Record Dates

• First Submitted: February 14, 2022
• First Posted: March 31, 2022
• Study Start: July 1, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Locations

CN (1)