Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.
NCT ID: NCT03150394
Last Updated: 2017-08-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
80 participants
INTERVENTIONAL
2017-04-04
2018-08-31
Brief Summary
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The eradication treatment of H. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. Standard treatment is based on multiple drug regimens. However, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. Therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are:
1. Determine whether the combination of two probiotic strains of L reuteri (Gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type).
2. Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy.
They will be determined by the GSRS gastrointestinal symptom scale in routine clinical practice.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment of quadruple eradication therapy with GASTRUS
GASTRUS
Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment
Treatment of quadruple eradication therapy with PLACEBO
PLACEBO
Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment
Interventions
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GASTRUS
Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment
PLACEBO
Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment
Eligibility Criteria
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Inclusion Criteria
* Age between 18 and 65 years
Exclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Dr. Luis Fernandez
OTHER
Responsible Party
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Dr. Luis Fernandez
PhD
Principal Investigators
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Dr. Fernandez Dr. Jesus Barrio
Role: STUDY_DIRECTOR
Managers study
Locations
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Hospital Clinico Universitario de Valladolid
Valladolid, , Spain
Hospital Universitario Río Hortega.
Valladolid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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VALACT-2017-01
Identifier Type: -
Identifier Source: org_study_id
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