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

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 Overview

• Status: Unknown
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Dietary supplement: GASTRUS; Other: PLACEBO

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Valladolid, Spain, 47003
    • Recruiting
    • Hospital Clinico Universitario de Valladolid
    • Contact: Luis Fernandez, PhD; Phone Number: +34607537815; Email: luisfernsal@gmail.com
  • Valladolid, Spain, 47012
    • Recruiting
    • Hospital Universitario Río Hortega.
    • Contact: Jesus Barrio, PhD; Email: jbarrioa95@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment of quadruple eradication therapy with GASTRUS	Dietary supplement: GASTRUS; Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment
Placebo Comparator: Treatment of quadruple eradication therapy with PLACEBO	Other: PLACEBO; Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Dr. Luis Fernandez
• Investigators: Study Director: Dr. Fernandez Dr. Jesus Barrio, Managers study

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2017
• Primary Completion (Anticipated): June 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 11, 2017
• First Posted (Actual): May 12, 2017

Study Record Updates

• Last Update Posted (Actual): August 25, 2017
• Last Update Submitted That Met QC Criteria: August 24, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Helicobacter Infections
• Other Study ID Numbers: VALACT-2017-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No