NCT01593592

Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Zagazig University · Other Government
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
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.
DIETARY_SUPPLEMENT	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
DRUG	Amoxicillin	amoxicillin 1000 mg b.i.d for 2 weeks
DRUG	Clarithromycin	clarithromycin 500mg b.i.d for 2 weeks

Timeline

• Start date: 2012-06-01
• Primary completion: 2013-01-01
• First posted: 2012-05-08
• Last updated: 2015-08-17
• Results posted: 2015-08-17

Locations

1 site across 1 country: Egypt