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

NCT03150394 | Unknown Phase 4

• 1 other identifier: VALACT-2017-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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. 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. 2.Prove whether supplementation with Gastrus (food supplement) versus Placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy.

Conditions

Helicobacter Pylori Infection

Outcome Measures

Primary Outcomes (1)

• Global score of gastrointestinal symptoms assessed according the GSRS scale

  30 days

Secondary Outcomes (1)

• Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment

  60 days

Study Arms (2)

Treatment of quadruple eradication therapy with GASTRUS

EXPERIMENTAL

Dietary Supplement: GASTRUS

Treatment of quadruple eradication therapy with PLACEBO

PLACEBO COMPARATOR

Other: PLACEBO

Interventions

GASTRUS DIETARY_SUPPLEMENT

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

Treatment of quadruple eradication therapy with GASTRUS

PLACEBO OTHER

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

Treatment of quadruple eradication therapy with PLACEBO

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients taking other probiotics 4 weeks prior to study start.
• Patients who have previously received eradicating therapy.
• Pregnancy

Sponsors & Collaborators

• Dr. Luis Fernandez: lead

Study Sites (2)

Hospital Clinico Universitario de Valladolid

Valladolid, 47003, Spain

RECRUITING

Hospital Universitario Río Hortega.

Valladolid, 47012, Spain

RECRUITING

Study Officials

• Dr. Fernandez Dr. Jesus Barrio

  Managers study

  STUDY DIRECTOR

Central Study Contacts

Luis Fernandez, PhD

CONTACT

+34607537815; luisfernsal@gmail.com

Jesus Barrio, PhD

CONTACT

jbarrioa95@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: May 5, 2017
• First Posted: May 12, 2017
• Study Start: April 4, 2017
• Primary Completion: June 1, 2018
• Study Completion: August 1, 2018
• Last Updated: August 25, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)