sefulness of the probiotic 'Lactobacillus reuteri' in the therapy of habitual eradication of infection Helicobacter pylori,

Phase 1

• Conditions: Helicobacter Pylori infection; MedDRA version: 19.1Level: LLTClassification code 10019377Term: Helicobacter pylori infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2017-000342-22-ES
• Lead Sponsor: Dr. Luis Fernández-Dr. Jesus Barrio

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-02-10
• Last Update Posted: 7 January 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients attended at the clinic visit who present a positive diagnosis of H pylori infection using different diagnostic techniques (C13 breath test, histology, urease and / or H pylori antigen in stools).
Age between 18 and 65 years.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Patients taking other probiotics 4 weeks prior to study start.
• Patients who have previously received eradicating therapy.
• Patients who are treated with NSAIDs, aspirin or other anti-inflammatory drugs either on an occasional basis (one week prior to the study) or on a chronic basis (3 weeks prior to inclusion).
• Patients who have used oral antibiotics two weeks prior to inclusion.
• Pregnancy.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified