Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

• ClinicalTrials.gov Identifier: NCT01593592
• Recruitment Status: Completed
• First Posted: May 8, 2012
• Results First Posted: August 17, 2015
• Last Update Posted: August 17, 2015
• Sponsor: Zagazig University
• Collaborator: BioGaia AB
• Information provided by (Responsible Party): Moahmed Hassan Emara, Zagazig University

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Helicobacter Pylori Infection	Dietary Supplement: Lactobacillus reuteri; Dietary Supplement: Placebo; Drug: Omeprazole; Drug: Amoxicillin; Drug: Clarithromycin	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial
• Study Start Date: June 2012
• Actual Primary Completion Date: January 2013

Arms and Interventions

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	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.; 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

Outcome Measures

Primary Outcome Measures :

1. Eradication of H Pylori Infection 4 Weeks After Completion of Therapy [ Time Frame: 4 weeks 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.

Secondary Outcome Measures :

1. Severe Adverse Effects to the Used Medications and Dietary Supplements. [ Time Frame: 4 weeks ]
2. The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. [ Time Frame: 8 weeks ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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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Contacts and Locations

Locations

Egypt

Zagazig University Hospitals

Zagazig, Sharkia, Egypt, 44519

Sponsors and Collaborators

Zagazig University

BioGaia AB

More Information

• Responsible Party: Moahmed Hassan Emara, Lecturer of Tropical Medicine and Hepatogastroenterology, Zagazig University
• ClinicalTrials.gov Identifier: NCT01593592
• Other Study ID Numbers: IRB#:395/29-4-2012; IRB#:395/29-4-2012 ( Other Identifier: Zagazig University )
• First Posted: May 8, 2012
• Results First Posted: August 17, 2015
• Last Update Posted: August 17, 2015
• Last Verified: July 2015

Keywords provided by Moahmed Hassan Emara, Zagazig University:

Helicobacter pylori; Lactobacillus reuteri; dyspeptic patients; eradication

Additional relevant MeSH terms:

Infections; Communicable Diseases; Helicobacter Infections; Disease Attributes; Pathologic Processes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Amoxicillin; Clarithromycin; Omeprazole; Anti-Bacterial Agents; Anti-Infective Agents; Anti-Ulcer Agents; Gastrointestinal Agents; Proton Pump Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Protein Synthesis Inhibitors; Cytochrome P-450 CYP3A Inhibitors; Cytochrome P-450 Enzyme Inhibitors