Clinical trial NCT05176821: Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection
Official title: Eradication Efficacy and Safety of High-dose Dual Therapy Compared With Furazolidone-based Quadruple Therapy as a Rescue Treatment for Helicobacter Pylori Infection: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: H. Pylori Infection
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2022-01-04
Enrollment: 186
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study was to evaluate the efficacy and safety of high-dose dual therapy compared with furazolidone-based quadruple therapy as a rescue treatment for helicobacter pylori infection.

Detailed description: Helicobacter pylori (H. pylori) infection is common worldwide and is strongly associated with peptic ulcer and gastric cancer. The eradication rate of H. pylori treatment is limited in the recent years although standard first-line therapy is used. There is a growing antibiotic resistance due to antibiotic consumption for other infections. The failure of first-line therapy for H. pylori can significantly limit the efficacy of the subsequent rescue therapies.

H. pylori resistance to amoxicillin (AMO), both primary and acquired, have been reported to be uncommon. The bactericidal effect of AMO against H. pylori is pH- and time- dependent with a sustaining higher intragastric pH. Thus, the therapy consisting of high-dose PPI and AMO may have advantage over the currently recommended furazolidone-based quadruple therapy.

Eligibility criteria: Inclusion Criteria:

* The patients who were diagnosed with persistent H. pylori infection and had previously failed one or more courses of eradication therapies that included amoxicillin, clarithromycin, or nitroimidazole.

Exclusion Criteria:

* Age \< 18 years old.
* The time frame was less than 6 months from the previous eradication therapy.
* The previous eradication therapy included furazolidone.
* Allergic to the medication.
* Pregnant or lactating women.
* Comorbidities of severe conditions like hepatic, renal or cardiorespiratory diseases or malignancy.
* Administration of antibiotics, bismuth or PPI in the preceding 4 weeks.

Primary outcomes:
measure: eradication rate
timeFrame: 42 days
Secondary outcomes:
measure: frequency of the adverse events
timeFrame: 42 days
measure: compliance rate of the drugs
timeFrame: 42 days
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital Xiamen Branch
Study officials:
affiliation: Xiamen branch of Zhongshan Hospital, Fudan University
name: Wei Jiang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yang J, Zhang Y, Fan L, Zhu YJ, Wang TY, Wang XW, Chen DF, Lan CH. Eradication Efficacy of Modified Dual Therapy Compared with Bismuth-Containing Quadruple Therapy as a First-Line Treatment of Helicobacter pylori. Am J Gastroenterol. 2019 Mar;114(3):437-445. doi: 10.14309/ajg.0000000000000132.
citation: Yu L, Luo L, Long X, Liang X, Ji Y, Graham DY, Lu H. High-dose PPI-amoxicillin dual therapy with or without bismuth for first-line Helicobacter pylori therapy: A randomized trial. Helicobacter. 2019 Aug;24(4):e12596. doi: 10.1111/hel.12596. Epub 2019 May 20.