Sequential Therapy Versus Quadruple Therapy in H. Pylori Eradication

Phase 4

• Conditions: Helicobacter
• Interventions: Drug: 14-day sequential therapy; Drug: Bismuth quadruple therapy

• Registration Number: NCT03156855
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-30
• Status Verified: 2017-05
• Study First Submitted QC: 2017-05-16
• Last Update Submitted: 2017-05-16
• Study First Posted: 2017-05-17
• Last Update Posted: 2017-05-17
• Primary Completion: 2018-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 620

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sequential therapy for 14 days (S14)	14-day sequential therapy	14 day sequential therapy
bismuth quadruple therapy (Q10)	Bismuth quadruple therapy	Bismuth quadruple therapy

Primary Outcome Measures

Name	Time	Method
Eradication rate: determined by urea breath test (13C-UBT, according to ITT analysis)	6 weeks	No eradicated divided by total cases by intention to treat analysis. 13C-UBT will be used to determine the H. pylori status at least 6 weeks after completion of treatment. A delta value of \> 4 units will be defined as positive for H. pylori infection as our previous studies.

Secondary Outcome Measures

Name	Time	Method
changes of antibiotic resistance	2 weeks, 8 weeks, 1 year	changes of antibiotic resistance of E. coli by per protocol analysis
adverse effect: occurrence of any adverse effect during the treatment	2 weeks	adverse effects related to treatment by per protocol analysis. The patients will be informed of the common side effects from the studied drugs prior to therapy. They will also be asked to record these symptoms during treatment. A standardized interview at the outpatient clinic at the end of treatment will be arranged. The adverse events and compliance will be assessed by the research staffs with pre-defined case report form.

Trial Locations

Locations (7)

Chiayi Christian Hospital; 🇨🇳 Chiayi City, Taiwan

E-DA University Hospital; 🇨🇳 Kaohsiung, Taiwan

National Taiwan University Hospital, Yun-Lin Branch; 🇨🇳 Yunlin County, Taiwan

National Taiwan University Hospital, Hsinchu Branch; 🇨🇳 Hsinchu, Taiwan

Mackay Memorial Hospital, Taitung branch; 🇨🇳 Taitung, Taiwan

Jyh-Ming Liou; 🇨🇳 Taipei, Taiwan

Taipei Veteran General Hospital; 🇨🇳 Taipei, Taiwan