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 Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03150394
• Other study ID #: VALACT-2017-01
• Status: Recruiting
• Phase: Phase 4
• First received: May 5, 2017
• Last updated: August 24, 2017
• Start date: April 4, 2017
• Est. completion date: August 2018

Study information

• Verified date: August 2017
• Source: Hospital Clínico Universitario de Valladolid
• Contact: Luis Fernandez, PhD
• Phone: +34607537815
• Email: luisfernsal[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: August 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infection

Intervention

Dietary Supplement:
• GASTRUS
Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment

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

Locations

Country	Name	City	State
Spain	Hospital Clinico Universitario de Valladolid	Valladolid
Spain	Hospital Universitario Río Hortega.	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Luis Fernandez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global score of gastrointestinal symptoms assessed according the GSRS scale		30 days
Secondary	Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment		60 days