Genotypic Resistance Guided Therapy for Refractory H. Pylori Infection

H Pylori Infection Clinical Trial

Official title:

Comparison of Genotypic Resistance Guided Versus Susceptibility Testing Guided Therapy for the Third-line Eradication of H. Pylori- a Multicenter Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03555526
• Other study ID #: 201706037MINC
• Status: Recruiting
• Phase: Phase 4
• Start date: December 15, 2017
• Est. completion date: December 31, 2021

Study information

• Verified date: December 2017
• Source: National Taiwan University Hospital
• Contact: Jyh-Ming Liou, MD, PhD
• Phone: 886972651883
• Email: jyhmingliou[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection.

Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection.

Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy.

Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis.

Description:

The inviestigators aimed to compare the efficacy of genotypic resistance guided versus susceptibility testing guided therapy in the third line treatment for refractory H. pylori infection.

Hypothesis:The investigators hypothesized that genotypic resistance guided sequential therapy is non-inferior to empiric therapy in the third line treatment for refractory H. pylori infection.

Methods: This multicenter, open label, parallel group, randomized trial will be conducted since 2017.07.20. Adult (≥20 years old) patients who failed from at least two eradication therapies for H. pylori infection will be enrolled. Genotypic and phenotypic resistances will be determined in patients who failed from at least two eradication therapies by polymerase-chain-reaction with direct sequencing and E-test and agar dilution test, respectively. Eligible patients will be randomized into either one of the treatment groups (A) genotypic resistance guided therapy; or (B) susceptibility testing guided therapy. Eradication status will be determined by 13C-urea breath test at least 6 weeks after eradication therapy. The stool samples will be collected before, and 2 and 8 weeks and 1 year after eradication therapy to analyze the changes in the antibiotic resistance and microbiota of gut flora. The body weight, waist and hip circumference and serum lipid profile, sugar, and HbA1C levels will also be collected before and 2 weeks, 8 weeks and 1 year after eradication therapy.

Outcome Measurement The primary outcome is the eradication rate in the third line treatment (genotypic versus susceptibility testing guided therapy) according to intention-to-treat (ITT) analysis.

Secondary End Points: the eradication rate according per protocol analysis and the adverse effects

Secondary End Point:

(A) Eradication rate according to per protocol analysis (PP analysis) (B) Frequency of adverse effects (C) The changes in the gut microbiota, antibiotic resistance of the Enterobacteriae, metabolic parameters before and after H. pylori eradication (D) The long term eradication rate and reinfection rate

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: December 31, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• H pylori infection failed after at least two eradication therapies

• aged 20 years or greater

• willingness to receive rescue therapy

Exclusion Criteria:

• aged less than 20 years

• history of gastric resection surgery

• history of allergy to study drugs

• pregnancy or lactating women

• severe underlying illness, such as end stage renal disease, decompensated liver cirrhosis, or non-curative malignancy

Related Conditions & MeSH terms

• H Pylori Infection
• Infection

Intervention

Drug:
• Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 14 days
• Amoxicillin
amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
• metronidazole
metronidazole, 500mg, bid, for 7 days (day 8-14)
• Levofloxacin 500mg
levofloxacin 250mg, bid, for 7 days (day 8-14)
• Clarithromycin ER
clarithromycin 500mg, bid, for 7 days (day 8-14)
• Esomeprazole 40mg
Nexium (esomeprazole), 40mg, bid, for 10 days
• Dibismuth trioxide
Dibismuth trioxide,KCB F.C. TABLETS,300mg,qid, for 10 days
• metronidazole
metronidazole, 500mg, tid, for 10 days (day 1-10)
• tetracycline
tetracycline 500mg, qid, for 10 days

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Eradication rate by intention to treat analysis		8 weeks
Secondary	Eradication rate by per protocol analysis		8 weeks
Secondary	frequency of adverse effects during eradication therapy		2 weeks
Secondary	changes of fecal microbiota	changes of fecal microbiota before and after erdication therapy	1 year
Secondary	reinfection rate	reinfection rate 1 year after eradication therapy	1 year