Helicobacter pylori is a Gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it. 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment
Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment
Hospital Clinico Universitario de Valladolid
Valladolid, Spain
RECRUITINGHospital Universitario Río Hortega.
Valladolid, Spain
RECRUITINGGlobal score of gastrointestinal symptoms assessed according the GSRS scale
Time frame: 30 days
Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment
Time frame: 60 days
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