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Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Primary Purpose

Helicobacter Pylori Infection

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Lactobacillus reuteri
Placebo
Omeprazole
Amoxicillin
Clarithromycin
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori, Lactobacillus reuteri, dyspeptic patients, eradication

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

      -

Sites / Locations

  • Zagazig University Hospitals

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Lactobacillus reuteri group

Control group

Arm Description

The active group that will receive the standard triple therapy and Lactobacillus reuteri

The control group that will receive the standard triple therapy and placebo

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Severe Adverse Effects to the Used Medications and Dietary Supplements.
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.

Full Information

First Posted
May 5, 2012
Last Updated
July 19, 2015
Sponsor
Zagazig University
Collaborators
BioGaia AB
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1. Study Identification

Unique Protocol Identification Number
NCT01593592
Brief Title
Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients
Official Title
Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University
Collaborators
BioGaia AB

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori, Lactobacillus reuteri, dyspeptic patients, eradication

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lactobacillus reuteri group
Arm Type
Experimental
Arm Description
The active group that will receive the standard triple therapy and Lactobacillus reuteri
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The control group that will receive the standard triple therapy and placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus reuteri
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Intervention Description
All patients will receive omeprazole 20 mg b.i.d for 2 week
Intervention Type
Drug
Intervention Name(s)
Amoxicillin
Intervention Description
amoxicillin 1000 mg b.i.d for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Clarithromycin
Intervention Description
clarithromycin 500mg b.i.d for 2 weeks
Primary Outcome Measure Information:
Title
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
Description
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.
Time Frame
4 weeks therapy
Secondary Outcome Measure Information:
Title
Severe Adverse Effects to the Used Medications and Dietary Supplements.
Time Frame
4 weeks
Title
The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.
Description
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.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Facility Information:
Facility Name
Zagazig University Hospitals
City
Zagazig
State/Province
Sharkia
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

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Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

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