Clinical trial NCT03150394: Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.
Official title: A Randomized, Double-blind, Placebo-controlled Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori Infection
Lead sponsor: Hospital Clínico Universitario de Valladolid
Sponsor class: OTHER
First posted: 2017-05-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

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

Primary outcomes:
measure: Global score of gastrointestinal symptoms assessed according the GSRS scale
timeFrame: 30 days
Secondary outcomes:
measure: Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment
timeFrame: 60 days
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Hospital Clinico Universitario de Valladolid
city: Valladolid
country: Spain
facility: Hospital Universitario Río Hortega.
Study officials:
affiliation: Managers study
name: Dr. Fernandez Dr. Jesus Barrio
role: STUDY_DIRECTOR
References: