Clinical trial NCT01593592: 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
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori
Lactobacillus reuteri
dyspeptic patients
eradication
Lead sponsor: Zagazig University
Sponsor class: OTHER_GOV
Collaborators: name: BioGaia AB
First posted: 2012-05-08
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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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Primary outcomes:
measure: Eradication of H Pylori Infection 4 Weeks After Completion of Therapy
timeFrame: 4 weeks therapy
Secondary outcomes:
measure: Severe Adverse Effects to the Used Medications and Dietary Supplements.
timeFrame: 4 weeks
measure: The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Zagazig
country: Egypt
facility: Zagazig University Hospitals
state: Sharkia
Study officials:
References: