Low Dose Bismuth Versus Lactobacillus Reuteri for H. Pylori Eradication

Study Overview
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Brief Summary
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This study investigates the efficacy of a b.i.d. quadruple therapy containing Pylera® or L. reuteri for H. pylori infection.

Detailed Description
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Bismuth, metronidazole and tetracycline yielded high cure rates for H. pylori infection. Earlier studies suggested that the bismuth quadruple therapy may be effective when given twice-a-day rather than q.i.d. and that b.i.d. therapy was associated with fewer side effects. The addition of the probiotic Lactobacillus reuteri (Gastrus®) to Lactobacillus reuteri (Gastrus®) that has been shown to increase the cure rates by 10-14%. In another study bismuth supplementation with L. reuteri DSM 17938, in a modified low dose quadruple therapy provided good eradication rates (93.3%; 95% CI : 85-99%) in clinical practice.

Official Title
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Twice-a-day PPI, Tetracycline, Metronidazolequadruple Therapy With Pylera® or Lactobacillus Reuteri for Treatment naïve or for Retreatment of H. Pylori: Two Randomized Pilot Studies

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Bismuth Subcitrate Potassium
* Dietary Supplement: Gastrus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Positive for H. pylori infection Exclusion Criteria: Presence of malignancy Pregnancy or lactation Clinically significant diseases History of drug or alcohol abuse Allergy to pantoprazole or to any component of regimens used in the study Use of anti-secretory drugs, antibiotics or probiotics 4 weeks preceding the enrollment.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: B.I.D. TMPPI + Lactobacillus-10<br>pantoprazole 20 mg, tetracycline 500 mg, and metronidazole 500 mg twice a day supplemented with 1 capsule (2 x 108 CFU of L. reuteri DSM 17938 plus 2 x 108 CFU of L. reuteri ATCC PTA 6475) a day in the afternoon, given with the midday and evening meals for 10 days | Drug: Bismuth Subcitrate Potassium<br>* Pylera capsules<br>* Other names: Metronidazole, Tetracycline, pantoprazole, Bismuth;|
| Active Comparator: B.I.D. Bismuth<br>pantoprazole 20 mg and the same doses of antibiotics administered as tetracycline 250 mg, and metronidazole 250 mg plus 1 cp (140 mg bismuth subcitrate potassium, 125 mg metronidazole, and 125 mg tetracycline hydrochloride administered) x 2 all drugs twice-a-day given with the midday and evening meals for 10 days | Dietary Supplement: Gastrus<br>* Gastrus 1 tablet<br>* Other names: L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Helicobacter pylori eradication rate | a negative 13C-urea breath test and/or a negative stool antigen test | 30-40 days after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance and side effects evaluation | Patient interview at the end of treatment | 30-40 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lactobacillus reuteri; Bismuth; Helicobacter pylori;