Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Study Overview
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Brief Summary
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Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

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.

Official Title
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Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Dietary Supplement: Lactobacillus reuteri
* Dietary Supplement: Placebo
* Drug: Omeprazole
* Drug: Amoxicillin
* Drug: Clarithromycin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion of patients with these criteria Age: 18-60 years Any sex Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool Good mentality to understand aim, benefits and steps of the study Assumed availability during the study period Written informed consent Exclusion Criteria: Exclusion of Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc. Patients with malignancy. Patients with gall bladder disorders. Patients with peptic ulcer. Patients with prior upper GIT surgery. Patients with probiotics therapy in the last one month. Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month. Patients with known allergy to the used medications -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lactobacillus reuteri group<br>The active group that will receive the standard triple therapy and Lactobacillus reuteri | Dietary Supplement: Lactobacillus reuteri<br>* 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.<br>Drug: Omeprazole<br>* All patients will receive omeprazole 20 mg b.i.d for 2 week<br>Drug: Amoxicillin<br>* amoxicillin 1000 mg b.i.d for 2 weeks<br>Drug: Clarithromycin<br>* clarithromycin 500mg b.i.d for 2 weeks<br>|
| Placebo Comparator: Control group<br>The control group that will receive the standard triple therapy and placebo | Dietary Supplement: Placebo<br>* 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.<br>Drug: Omeprazole<br>* All patients will receive omeprazole 20 mg b.i.d for 2 week<br>Drug: Amoxicillin<br>* amoxicillin 1000 mg b.i.d for 2 weeks<br>Drug: Clarithromycin<br>* clarithromycin 500mg b.i.d for 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eradication of H Pylori Infection 4 Weeks After Completion of Therapy | H. pylori eradication is defined in this study as concomitant negativity to all previously positive tests (H. pylori antigen in stool; histopathological confirmation of H. pylori bacilli; and rapid urease test.) 4 weeks after the end of therapy. | 4 weeks therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe Adverse Effects to the Used Medications and Dietary Supplements. |  | 4 weeks | 
| The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. | Severe adverse effects to the used medications and dietary supplements, these may expose the participants to major morbidity and may change the outcomes in them. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori, Lactobacillus reuteri, dyspeptic patients, eradication