Sequential Versus Quadruple Therapy in the Second-line Treatment

Helicobacter Pylori Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03208426
• Other study ID #: 201611053MINA
• Status: Recruiting
• Phase: Phase 4
• Start date: October 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2018
• Source: National Taiwan University Hospital
• Contact: Jyh-Ming Liou, MD, PhD
• Phone: 886-2-23123456
• Email: jyhmingliou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Drug:
• Esomeprazole (S14)
Nexium, esomeprazole 40mg bid, 14 days
• Esomeprazole (BQ10)
Nexium, esomeprazole, 40mg bid for 10 days
• Amoxicillin (ST14)
Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
• Clarithromycin (ST14)
Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
• Metronidazole (ST14)
Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
• dibismuth trioxide 120mg (BQ10)
KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
• Metronidazole (BQ10)
Flagyl, metronidazole 500mg tid for 10 days
• tetracycline (BQ10)
Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days

Locations

Country	Name	City	State
Taiwan	Jyh-Ming Liou	Taipei, Taiwan

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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 trea — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	eradication rate in the second-line treatment according to intention to treat (ITT) analysis	Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Successful eradication of H. pylori will be defined as a negative 13C-UBT result. A positive 13C-UBT test will be defined as a delta value of 4 units or greater. All subjects will be asked to stop PPI and H2-blocker for at least two weeks before 13C-UBT.	6 weeks
Secondary	Incidence of adverse effects in the first line therapy in the two treatment groups	At enrollment, the patients will be informed of the common side effects from the studied drugs and they will be asked to record these symptoms during treatment. A standardized interview and questionnaire will be used to assess the adverse events	2 weeks
Secondary	Eradication rates in the second line treatment according to per protocol (PP) analysis	Urea breath test will be performed at least 6 weeks after the end of eradication therapy. Patients not follow the protocol will be excluded for PP analysis.	6 weeks
Secondary	Changes of gut microbiota in the two treatment groups	the stool specimens before, 2weeks after, 8 weeks after, and 1 year after the treatment will be collected for gut microbiota analysis	2 weeks, 8 weeks, and 1 year
Secondary	Re-infection rate one year after eradication therapy	Urea breath test will be performed 1 year after the end of eradication therapy.	1 year