actobacillus reuteri Supplementation for Helicobacter pylori Eradication among Patients with Dyspepsia

Phase 2

Recruiting

Conditions: Condition 1: Functional dyspepsia. Condition 2: Helicobacter pylori.
Functional dyspepsia
Helicobacter pylori [H. pylori] as the cause of diseases classified elsewhere
B96.81

Registration Number: IRCT20141201020178N10

Lead Sponsor: Iran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 80

Inclusion Criteria

Patients aged between 18 to 70 years old with dyspepsia presentation
H. Pylori documentation by antral biopsy (Rapid Urease Test or Giemsa staining) or Urea Breath Test

Exclusion Criteria

Pregnancy or breast- feeding
Women taking oral contraceptive pill (OCP)
Significant underlying diseases such as cardiac, pulmonary, renal, liver, endocrine, central nervous system (CNS) diseases and cancers
Previous history of gastric surgery
Patients taking triple therapy for H. Pylori eradication
History of taking proton pump inhibitor (PPI), histamine H2- receptor blocker (H2B) or antibiotic during previous two weeks
Concomitant use of anticoagulant or corticosteroid
Previous history of taking monoamine oxidase (MAO) inhibitors or tricyclic antidepressants (TCA)

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Helicobacter Pylori eradication rate. Timepoint: Six weeks after the end of therapy. Method of measurement: Stool Antigen Test.

Secondary Outcome Measures

Name	Time	Method
Rate of supplementation's side effects. Timepoint: After end of the therapy. Method of measurement: Patients' follow-up checklist.;Patient's compliance rate. Timepoint: After end of the therapy. Method of measurement: Patients' follow-up checklist.