Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

Helicobacter Pylori Infection Clinical Trial

Official title:

Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients: a Double Blind Placebo Controlled Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01593592
• Other study ID #: IRB#:395/29-4-2012
• Secondary ID: IRB#:395/29-4-20
• Status: Completed
• Phase: N/A
• First received: May 5, 2012
• Last updated: July 19, 2015
• Start date: June 2012

Study information

• Verified date: July 2015
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Zagazig University
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

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.
• 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
• Amoxicillin
amoxicillin 1000 mg b.i.d for 2 weeks
• Clarithromycin
clarithromycin 500mg b.i.d for 2 weeks

Locations

Country	Name	City	State
Egypt	Zagazig University Hospitals	Zagazig	Sharkia

Sponsors (2)

Lead Sponsor	Collaborator
Zagazig University	BioGaia AB

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 weeks therapy	No
Secondary	Severe Adverse Effects to the Used Medications and Dietary Supplements.		4 weeks	Yes
Secondary	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.	8 weeks	Yes

External Links

•   Home institution
•   Study location Hospital