Eradication Efficacy and Safety of Two Rescue Treatments for Helicobacter Pylori Infection

H. Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05176821
• Other study ID #: JW-Hp2021
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Jie Chen, MD
• Phone: 8613764633539
• Email: chen.jie5[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 186
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• H. Pylori Infection
• Infections

Intervention

Drug:
• esomeprazole plus amoxicillin
amoxicillin 750mg QID + esomeprazole 20mg QID for 14 days
• amoxicillin, furazolidone, bismuth potassium citrate , esomeprazole
amoxicillin 1000mg BID + furazolidone 100mg BID + bismuth potassium citrate 600mg BID + esomeprazole 20mg BID for 14 days

Locations

Country	Name	City	State
China	Zhongshan Hospital Xiamen Branch	Xiamen

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Erratum in: Am J Gastroenterol. 2019 May;114(5):835. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eradication rate	eradication rate of H pylori, presenting with negative results on the 13C-UBT test	42 days
Secondary	frequency of the adverse events	incidence rate of the adverse events, including dyspepsia, nausea, vomiting, abdominal pain, bloating, diarrhea, dizziness, headache, skin rash, fatigue and fever.	42 days
Secondary	compliance rate of the drugs	Compliance was defined as good when they had taken more than 80% of the total medication.	42 days