Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Not Applicable

Completed

• Conditions: Helicobacter Pylori Infection
• Interventions: Dietary Supplement: Lactobacillus reuteri; Dietary Supplement: Placebo; Drug: Omeprazole; Drug: Amoxicillin; Drug: Clarithromycin

• Registration Number: NCT01593592
• Lead Sponsor: Zagazig University

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.

Study Timeline

• Study First Submitted: 2012-05-05
• Study First Submitted QC: 2012-05-07
• Study First Posted: 2012-05-08
• Study Start: 2012-06
• Primary Completion: 2013-01
• Results First Submitted: 2015-03-07
• Status Verified: 2015-07
• Results First Submitted QC: 2015-07-19
• Last Update Submitted: 2015-07-19
• Results First Posted: 2015-08-17
• Last Update Posted: 2015-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lactobacillus reuteri group	Amoxicillin	The active group that will receive the standard triple therapy and Lactobacillus reuteri
Lactobacillus reuteri group	Lactobacillus reuteri	The active group that will receive the standard triple therapy and Lactobacillus reuteri
Control group	Placebo	The control group that will receive the standard triple therapy and placebo
Lactobacillus reuteri group	Omeprazole	The active group that will receive the standard triple therapy and Lactobacillus reuteri
Lactobacillus reuteri group	Clarithromycin	The active group that will receive the standard triple therapy and Lactobacillus reuteri
Control group	Omeprazole	The control group that will receive the standard triple therapy and placebo
Control group	Amoxicillin	The control group that will receive the standard triple therapy and placebo
Control group	Clarithromycin	The control group that will receive the standard triple therapy and placebo

Primary Outcome Measures

Name	Time	Method
Eradication of H Pylori Infection 4 Weeks After Completion of Therapy	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

Name	Time	Method
The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.	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.
Severe Adverse Effects to the Used Medications and Dietary Supplements.	4 weeks

Trial Locations

Locations (1)

Zagazig University Hospitals; 🇪🇬 Zagazig, Sharkia, Egypt