Effectiveness of Once-daily Dose Regimen of 7-day and 14-day High Dose Rabeprazole-levofloxacin Based Quadruple Therapy for H. Pylori Eradication in Thai Patients With Non-ulcer Dyspepsia

Thammasat University

Status and phase: Unknown; Phase 1

Conditions: Helicobacter Pylori Infection

Treatments: Diagnostic Test: 13C Urea Breath Test

Study type: Interventional

Funder types: Other

Identifiers

NCT03397680

MTU-EC-IM-2-200/59

Details and patient eligibility

About

H.pylori is an organism which causes gastric inflammation, peptic ulcer disease (PUD), mucosa associated lymphoid tissue (MALT) lymphoma and gastric cancer.

Practical guideline for treatment of patients with dyspepsia and H.pylori eradication recommended the 14-day triple therapy regimen which had curable about 70% by using proton pump inhibitor (PPI) combined with antibiotics including amoxicillin, clarithromycin and metronidazole.

Up to date, there has been no evidence about the cure rate for H.pylori eradication with once-daily dose regimen of high dose rabeprazole and levofloxacin based therapy. This research is to study the 7-day and 14-day cure rate of H.pylori eradication treatment with once-daily regimen of high dose rabeprazole-levofloxacin based quadruple therapy.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Thai patients with the age between 18 and 70 years
• Detecting for H.pylori infection with positive urease test and/or pathological findings of H.pylori and/or positive

Exclusion criteria

1. Any cases with upper gastrointestinal bleeding
2. Being treated with medications affecting the research outcome, for example, by using antibiotics including amoxicillin, clarithromycin, metronidazole or fluoroquinolone within 1 month before the enrollment.
3. Contraindicated for gastric biopsy such as coagulopathy.
4. Any history of drug allergy for levofloxacin, clarithromycin or rabeprazole.
5. Receiving proton pump inhibitor within 4 weeks or receiving any antibiotics or bismuth within 2 weeks.
6. Being pregnant or raising children with lactation.
7. Having history of H.pylori eradication treatment.
8. Having severe underlying disease including end-stage renal disease requiring hemodialysis or peritoneal dialysis (GFR < 15), cirrhosis with Child-Pugh classification grade C, immunocompromised host with AIDS, malignancy and/or bed ridden cerebrovascular disease.
9. Any cases who receiving anticoagulant.
10. Having previous gastric surgery.
11. Unwilling to participate into research.
12. Having history of taking previous medications which interacted with the research treatment.
13. Having underlying heart disease including congenital long QT syndrome.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Rabeprazole-levofloxacin based quadruple therapy for 7 days

Active Comparator group

Description:

Participant will received 7-day once daily dose regimen of 1-tablet 750-mg Levofloxacin after meal, 2-tablet 500-mg Clarithromycin MR after meal, 3-tablet 20-mg Rabeprazole before meal and 1-tablet 1,048-mg Gastro bismol after meal.

Treatment:

Diagnostic Test: 13C Urea Breath Test

Rabeprazole-levofloxacin based quadruple therapy for14 days

Active Comparator group

Description:

Pparticipant will received 14-day once daily dose regimen of 1-tablet 750-mg Levofloxacin after meal, 2-tablet 500-mg Clarithromycin MR after meal, 3-tablet 20-mg Rabeprazole before meal and 1-tablet 1,048-mg Gastro bismol after meal

Treatment:

Diagnostic Test: 13C Urea Breath Test