Clinical trial NCT03208426: Sequential Versus Quadruple Therapy in the Second-line Treatment
Official title: Comparison of the Efficacy of 14-day Sequential Therapy and 10-day Bismuth Quadruple Therapy in the Second Line Therapy for Helicobacter Pylori Infection: A Multi-center Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Keywords: Efficacy, Self
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-07-05
Enrollment: 240
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: Objectives: A recent randomized trial showed that 14-day sequential therapy containing high dose proton pump inhibitor was higher than 95% in the first line treatment. However, whether the 14-day sequential therapy is more effective than 10-day bismuth quadruple therapy remains unknown. Therefore, the investigators aimed to 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 second line treatment.

Detailed description: This will be a multi-center, open labeled, randomized comparative trial Patients: 240 patients with H. pylori infection who failed after first-line therapy will be eligible

Interventions: eligible patients will be randomized into one of the two groups Group (A): sequential therapy for 14 days (S14)

D1-D7: (esomeprazole 40mg bid + amoxicillin 1000mg bid) for 7 days

D8-D14: (esomeprazole 40mg bid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days

Group (B): bismuth quadruple therapy for 10 days (Q10)

D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days

Primary End Point: Eradication rate in the second line treatment according to intention to treat (ITT) analysis in the two treatment groups

Eligibility criteria: Inclusion Criteria:

* H. pylori infected patients who fail from first line standard triple therapy with clarithromycin, amoxicillin, and a proton pump inhibitor will be eligible in this study.

Exclusion Criteria:

Patients will be excluded from the study if any one of the following criteria was present:

* children and teenagers aged less than 20 years,
* history of gastrectomy,
* gastric malignancy, including adenocarcinoma and lymphoma,
* previous allergic reaction to antibiotics (bismuth, metronidazole, levofloxacin, tetracycline) and PPI (esomeprazole),
* contraindication to treatment drugs,
* pregnant or lactating women,
* severe concurrent disease, or
* Unwilling to accept random assignment of subjects.

Primary outcomes:
measure: eradication rate in the second-line treatment according to intention to treat (ITT) analysis
timeFrame: 6 weeks
Secondary outcomes:
measure: Incidence of adverse effects in the first line therapy in the two treatment groups
timeFrame: 2 weeks
measure: Eradication rates in the second line treatment according to per protocol (PP) analysis
timeFrame: 6 weeks
measure: Changes of gut microbiota in the two treatment groups
timeFrame: 2 weeks, 8 weeks, and 1 year
measure: Re-infection rate one year after eradication therapy
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei, Taiwan
country: Taiwan
facility: Jyh-Ming Liou
Study officials:
affiliation: National Taiwan University Hospital
name: Jyh-Ming Liou, MD, PhD
role: STUDY_CHAIR
affiliation: National Taiwan University Hospital, Yun-Lin Branch
name: Yu-Jen Fang, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Liou JM, Fang YJ, Chen CC, Bair MJ, Chang CY, Lee YC, Chen MJ, Chen CC, Tseng CH, Hsu YC, Lee JY, Yang TH, Luo JC, Chang CC, Chen CY, Chen PY, Shun CT, Hsu WF, Hu WH, Chen YN, Sheu BS, Lin JT, Wu JY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Concomitant, bismuth quadruple, and 14-day triple therapy in the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2016 Nov 12;388(10058):2355-2365. doi: 10.1016/S0140-6736(16)31409-X. Epub 2016 Oct 18.
citation: Liou JM, Chen CC, Chen MJ, Chen CC, Chang CY, Fang YJ, Lee JY, Hsu SJ, Luo JC, Chang WH, Hsu YC, Tseng CH, Tseng PH, Wang HP, Yang UC, Shun CT, Lin JT, Lee YC, Wu MS; Taiwan Helicobacter Consortium. Sequential versus triple therapy for the first-line treatment of Helicobacter pylori: a multicentre, open-label, randomised trial. Lancet. 2013 Jan 19;381(9862):205-13. doi: 10.1016/S0140-6736(12)61579-7. Epub 2012 Nov 16.