Skip to main content
OpenTrials
Completed

NCT Number: NCT01593592

Lactobacillus Reuteri in Management of Helicobacter Pylori Infection in Dyspeptic Patients

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Helicobacter Pylori Infection

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zagazig University Hospitals

Zagazig, Sharqia Province, 44519, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion of patients with these criteria

  • Age: 18-60 years
  • Any sex
  • Confirmed H. Pylori infection defined by pathological lesions and either histopathological confirmation of the organism, rapid urease test or H. Pylori antigen in stool
  • Good mentality to understand aim, benefits and steps of the study
  • Assumed availability during the study period
  • Written informed consent

Exclusion criteria

  • Exclusion of
  • Patients with chronic diseases e.g. diabetes, renal failure, cirrhosis…etc.
  • Patients with malignancy.
  • Patients with gall bladder disorders.
  • Patients with peptic ulcer.
  • Patients with prior upper GIT surgery.
  • Patients with probiotics therapy in the last one month.
  • Patients with triple therapy, antibiotics, proton pump inhibitors and H2 receptor blockers therapy within one month.
  • Patients with known allergy to the used medications

-

Treatment and study plan

Lactobacillus reuteri

Dietary Supplement

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

Dietary Supplement

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.

Omeprazole

Drug

All patients will receive omeprazole 20 mg b.i.d for 2 week

Amoxicillin

Drug

amoxicillin 1000 mg b.i.d for 2 weeks

Clarithromycin

Drug

clarithromycin 500mg b.i.d for 2 weeks

Primary outcomes

  1. Eradication of H Pylori Infection 4 Weeks After Completion of Therapy

    Time frame: 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 outcomes

  1. Severe Adverse Effects to the Used Medications and Dietary Supplements.

    Time frame: 4 weeks

  2. The Secondary End Point Was the Development of Severe Adverse Effects to the Used Medications and Dietary Supplements.

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Collaborators

  • BioGaia AB

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
First posted
May 8, 2012
Registry last updated
Aug 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.