Clinical trial NCT03156855: Sequential Therapy Versus Quadruple Therapy in H. Pylori Eradication
Official title: Comparison of the Efficacy of Sequential Therapy and Bismuth Quadruple Therapy in the First Line and Second Line Therapy for Helicobacter Pylori Infection- A Multi-center Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter
Keywords: efficacy
safety
H. pylori eradication
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: E-DA Hospital
name: National Taiwan University Hospital Hsin-Chu Branch
name: Taipei Veterans General Hospital, Taiwan
name: Kaohsiung Medical University
name: Chiayi Christian Hospital
name: Mackay Memorial Hospital
First posted: 2017-05-17
Enrollment: 620
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators aimed to

1. compare the eradication rates and long term re-infection rates of sequential therapy for 14 days versus bismuth quadruple therapy for 10 days in the first line and second line treatment
2. assess the impact of antibiotic resistance and CYP2C19 polymorphism on the eradication rate of these regimens
3. assess the impact of these eradication regimens on the antibiotic resistance and microbiota of the gut flora
4. assess the impact of eradication therapy on the metabolic factors

Detailed description: Helicobacter pylori infection has been shown to be associated with the development of gastric cancer and peptic ulcer diseases. Eradication of H. pylori infection reduces the risk of gastric cancer and recurrence of peptic ulcer disease. However, the eradication rate of clarithromycin-based triple therapy has been declining in recent years, probably related to the increasing resistant rate to clarithromycin. Sequential therapy for 10 days has been shown to be more effective than triple therapy for 7 and 10 days. The investigators further demonstrated that sequential therapy given for 14 days was superior to triple therapy given for 14 days. Recently, the investigators also found that bismuth quadruple therapy given for 10 days appeared to be more effective than triple therapy given for 14 days in the first line therapy. However, whether sequential therapy given for 14 days is more effective than bismuth quadruple therapy or triple therapy for 14 days remains unknown.

Eligibility criteria: Inclusion Criteria:

1. H. pylori infected patients naïve to eradication therapies will be eligible in this study.

Exclusion Criteria:

1. children and teenagers aged less than 20 years,
2. history of gastrectomy,
3. gastric malignancy, including adenocarcinoma and lymphoma,
4. previous allergic reaction to antibiotics (bismuth, amoxicillin, metronidazole, clarithromycin, tetracycline) and PPI (esomeprazole),
5. contraindication to treatment drugs,
6. pregnant or lactating women,
7. severe concurrent disease,
8. concomitant use of clopidogrel, or (9) Unwilling to accept random assignment of subjects

Primary outcomes:
measure: Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)
timeFrame: 6 weeks
Secondary outcomes:
measure: adverse effect: occurrence of any adverse effect during the treatment
timeFrame: 2 weeks
measure: changes of antibiotic resistance
timeFrame: 2 weeks, 8 weeks, 1 year
Other outcomes:
measure: changes of gut microbiota
timeFrame: 2 weeks, 8 weeks, 1 year
Locations:
city: Chiayi City
country: Taiwan
facility: Chiayi Christian Hospital
city: Hsinchu
country: Taiwan
facility: National Taiwan University Hospital, Hsinchu Branch
city: Kaohsiung
country: Taiwan
facility: E-DA University Hospital
city: Taipei
country: Taiwan
facility: Jyh-Ming Liou
city: Taipei
country: Taiwan
facility: Taipei Veteran General Hospital
city: Taitung
country: Taiwan
facility: Mackay Memorial Hospital, Taitung branch
city: Yunlin County
country: Taiwan
facility: National Taiwan University Hospital, Yun-Lin Branch
Study officials:
affiliation: National Taiwan University Hospital
name: Ming-Shiang Wu, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Liou JM, Chen CC, Fang YJ, Chen PY, Chang CY, Chou CK, Chen MJ, Tseng CH, Lee JY, Yang TH, Chiu MC, Yu JJ, Kuo CC, Luo JC, Hsu WF, Hu WH, Tsai MH, Lin JT, Shun CT, Twu G, Lee YC, Bair MJ, Wu MS; Members of the Taiwan Gastrointestinal Disease and Helicobacter Consortium. 14 day sequential therapy versus 10 day bismuth quadruple therapy containing high-dose esomeprazole in the first-line and second-line treatment of Helicobacter pylori: a multicentre, non-inferiority, randomized trial. J Antimicrob Chemother. 2018 Sep 1;73(9):2510-2518. doi: 10.1093/jac/dky183.