Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

Sponsor

University of Split, School of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT04621487

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Non-bismuth quadruple therapies have been proposed as potential strategies in improving the efficacy of first-line treatments. The non-bismuth quadruple therapy in its concomitant variant consists of proton pump inhibitor, amoxicillin, nitroimidazole and clarithromycin given concurrently twice daily. As a result of concurrent administration this therapy has given better results according to some studies in comparison to sequential variants. However, this therapy, as well suffers from the aforementioned increase in antibiotic resistance. Therefore, the aim of this study was to compare concomitant non-bismuth quadruple therapy with a tailored therapy based on antibiotic strain susceptibility testing.

Condition or Disease	Intervention/Treatment	Phase
Helicobacter Pylori Infection	Drug: Amoxicillin Drug: Metronidazole Drug: Clarithromycin Drug: Pantoprazole 40mg Drug: according to antibiogram	N/A

Detailed Description

More than half of world population are H.pylori carriers. The infection is mostly acquired in childhood and persists lifelong. A notable risk factor is a lower social and economic status during childhood reflecting mostly poor hygienic standard or small and dense living area. Newly acquired infections in adulthood are a rarity. The reservoir of H. Pylori is the human stomach. H. pylori is considered to be the main pathogen involved in causing benign peptic ulcer and functional dyspepsia as well as gastric cancer. The treatment of H. Pylori infection is currently complicated by an increase in antimicrobial resistance in different parts of the world. Corresponding increase in clarithromycin as well as quinolone and metronidazole resistance poses a major clinical problem and calls for a new approach to treatment. Under such circumstances there is an emerging trend towards personalized eradication therapy. Since H. Pylori infection is an infectious disease its optimal treatment should both theoretically and practically be based on the specific characteristics of the strain and if possible the host of the infection. The aim of such an approach should be a better eradication efficacy.

Study Design

Study Type:

Interventional

Actual Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized Controlled Trial: Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection

Actual Study Start Date :

Jan 15, 2019

Actual Primary Completion Date :

Jan 15, 2020

Actual Study Completion Date :

Feb 15, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: concomitant Concomitant therapy consists of 14 days pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, metronidazole 500 mg all twice daily.	Drug: Amoxicillin 14 days 1 gr bid Drug: Metronidazole 14 days 500 mg bid Drug: Clarithromycin 14 days 500 mg bid Drug: Pantoprazole 40mg 40 mg bid 14 days Other Names: Pantoprazole
Active Comparator: tailored Tailored therapy consists of 14 days antibiotic therapy according to H. Pylori strains antibiotic sensitivity test together with pantoprazole 40 mg twice daily.	Drug: according to antibiogram according to antibiogram

Arm

Intervention/Treatment

Active Comparator: concomitant

Concomitant therapy consists of 14 days pantoprazole 40 mg, amoxicillin 1000 mg, clarithromycin 500 mg, metronidazole 500 mg all twice daily.

Drug: Amoxicillin

14 days 1 gr bid

Drug: Metronidazole

14 days 500 mg bid

Drug: Clarithromycin

14 days 500 mg bid

Drug: Pantoprazole 40mg

40 mg bid 14 days

Other Names:

Pantoprazole

Active Comparator: tailored

Tailored therapy consists of 14 days antibiotic therapy according to H. Pylori strains antibiotic sensitivity test together with pantoprazole 40 mg twice daily.

Drug: according to antibiogram

according to antibiogram

Outcome Measures

Primary Outcome Measures

eradication [1 month after finishing therapy]
H.pylori status will be tested 1 month after therapy with a stool antigen test: positive or negative

Secondary Outcome Measures

compliance [1 month after finishing therapy]
compliance will be measured by counting pills that were taken during therapy, more than or equal to 80% will be considered as good compliance
adverse event [1 month after finishing therapy]
patients will be asked to report any adverse events that occurred during treatment, they will be divided in groups, according to the degree of limitation of daily activities: no adverse events, mild (no limitations of activities), moderate (partially limited activities), severe (completely limited)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

helicobacter pylori infection

Exclusion Criteria:

previous unsuccessful eradication treatment, stomach or other malignancy, taking of proton pump inhibitors, H2-antagonists, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in the previous month, significant comorbidities (renal insufficiency, psychiatric disease), denial to participate in the study, history of allergy to proton pump inhibitors or antibiotics, pregnancy and lactation.