Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.

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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03150394

Enrollment

Registered

2017-05-12

Start date

2017-04-04

Completion date

2018-08-31

Last updated

2017-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori Infection

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.

Interventions

DIETARY_SUPPLEMENTGASTRUS

Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment

OTHERPLACEBO

Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Global score of gastrointestinal symptoms assessed according the GSRS scale	30 days

Secondary

Measure	Time frame
Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment	60 days

Countries

Spain

Contacts

Primary ContactLuis Fernandez, PhD

luisfernsal@gmail.com+34607537815

Backup ContactJesus Barrio, PhD

jbarrioa95@gmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026