Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

This study has been completed.
Sponsor:
Collaborator:
BioGaia AB
Information provided by (Responsible Party):
Moahmed Hassan Emara, Zagazig University
ClinicalTrials.gov Identifier:
NCT01593592
First received: May 5, 2012
Last updated: July 19, 2015
Last verified: July 2015
  Purpose
Addition of L. reuteri to the standard triple therapy improves H. Pylori treatment outcomes.

Condition Intervention
Helicobacter Pylori Infection
Dietary Supplement: Lactobacillus reuteri
Dietary Supplement: Placebo
Drug: Omeprazole
Drug: Amoxicillin
Drug: Clarithromycin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Zagazig University:

Primary Outcome Measures:
  • Eradication of H Pylori Infection 4 Weeks After Completion of Therapy [ Time Frame: 4 weeks therapy ] [ Designated as safety issue: No ]
    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:
  • Severe Adverse Effects to the Used Medications and Dietary Supplements. [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
  • The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements. [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 70
Study Start Date: June 2012
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Genders Eligible for Study:   Both
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01593592

Locations
Egypt
Zagazig University Hospitals
Zagazig, Sharkia, Egypt, 44519
Sponsors and Collaborators
Zagazig University
BioGaia AB
  More Information

Additional Information:
Responsible Party: Moahmed Hassan Emara, Lecturer of Tropical Medicine and Hepatogastroenterology, Zagazig University
ClinicalTrials.gov Identifier: NCT01593592     History of Changes
Other Study ID Numbers: IRB#:395/29-4-2012  IRB#:395/29-4-2012 
Study First Received: May 5, 2012
Results First Received: March 7, 2015
Last Updated: July 19, 2015
Health Authority: Egypt: Zagazig University

Keywords provided by Zagazig University:
Helicobacter pylori
Lactobacillus reuteri
dyspeptic patients
eradication

Additional relevant MeSH terms:
Infection
Communicable Diseases
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
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

ClinicalTrials.gov processed this record on August 23, 2016