Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

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

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

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: Lactobacillus reuteri; Drug: Omeprazole; Drug: Amoxicillin; Drug: Clarithromycin; Dietary supplement: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Sharkia
    • Zagazig, Sharkia, Egypt, 44519
      • Zagazig University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zagazig University
• Collaborators: BioGaia AB

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: May 5, 2012
• First Submitted That Met QC Criteria: May 7, 2012
• First Posted (Estimate): May 8, 2012

Study Record Updates

• Last Update Posted (Estimate): August 17, 2015
• Last Update Submitted That Met QC Criteria: July 19, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Helicobacter pylori; eradication; Lactobacillus reuteri; dyspeptic patients
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Gastrointestinal Agents; Anti-Bacterial Agents; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors; Protein Synthesis Inhibitors; Anti-Ulcer Agents; Proton Pump Inhibitors; Amoxicillin; Clarithromycin; Omeprazole
• Other Study ID Numbers: IRB#:395/29-4-2012 (Other Identifier: Zagazig University)