Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Zagazig University

Status: Completed

Conditions: Helicobacter Pylori Infection

Treatments: Drug: Clarithromycin; Dietary Supplement: Lactobacillus reuteri; Drug: Amoxicillin; Drug: Omeprazole; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01593592

IRB#:395/29-4-2012 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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70 participants in 2 patient groups, including a placebo group

Lactobacillus reuteri group

Experimental group

Description:

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

Treatment:

Drug: Clarithromycin

Drug: Amoxicillin

Drug: Omeprazole

Dietary Supplement: Lactobacillus reuteri

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Drug: Clarithromycin

Drug: Amoxicillin

Drug: Omeprazole