Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Brief Summary

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Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

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Detailed Description

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Helicobacter pylori (H. Pylori) infection is a wide spread disease and is endemic in many countries including Egypt with a wide range of morbidity; that requires appropriate antimicrobial therapy . However, worldwide the eradication rate following the standard triple therapy is declining and this may necessitates introduction of new antimicrobial agents . On the sight of bearing in vivo and in vitro activity against H. Pylori, the use of different strains of probiotics in treatment of H. Pylori may be thus justifiable, Lactobacillus reuteri (L. reuteri) which through different mechanisms including production of reuterin have anti H.pylori activity have been tried in improving the eradication rates of H.pylori with contradictory results . This study is conducted to test the assumption that addition of L. reuteri to the standard triple therapy in treatment of H. Pylori improves the eradication rates and clinical aspects in H. Pylori infection.

Conditions

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Helicobacter Pylori Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Lactobacillus reuteri group

The active group that will receive the standard triple therapy and Lactobacillus reuteri

Group Type EXPERIMENTAL

Lactobacillus reuteri

Intervention Type DIETARY_SUPPLEMENT

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.

Omeprazole

Intervention Type DRUG

All patients will receive omeprazole 20 mg b.i.d for 2 week

Amoxicillin

Intervention Type DRUG

amoxicillin 1000 mg b.i.d for 2 weeks

Clarithromycin

Intervention Type DRUG

clarithromycin 500mg b.i.d for 2 weeks

Control group

The control group that will receive the standard triple therapy and placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.

Omeprazole

Intervention Type DRUG

All patients will receive omeprazole 20 mg b.i.d for 2 week

Amoxicillin

Intervention Type DRUG

amoxicillin 1000 mg b.i.d for 2 weeks

Clarithromycin

Intervention Type DRUG

clarithromycin 500mg b.i.d for 2 weeks

Interventions

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Lactobacillus reuteri

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.

Intervention Type DIETARY_SUPPLEMENT

Omeprazole

All patients will receive omeprazole 20 mg b.i.d for 2 week

Intervention Type DRUG

Amoxicillin

amoxicillin 1000 mg b.i.d for 2 weeks

Intervention Type DRUG

Clarithromycin

clarithromycin 500mg b.i.d for 2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Inclusion of patients with these criteria

1. Age: 18-60 years
2. Any sex
3. Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
4. Good mentality to understand aim, benefits and steps of the study
5. Assumed availability during the study period
6. Written informed consent

Exclusion Criteria

* Exclusion of

1. Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc.
2. Patients with malignancy.
3. Patients with gall bladder disorders.
4. Patients with peptic ulcer.
5. Patients with prior upper GIT surgery.
6. Patients with probiotics therapy in the last one month.
7. Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.
8. Patients with known allergy to the used medications

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Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No