Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.
Primary Purpose
Helicobacter Pylori Infection
Status
Unknown status
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
GASTRUS
PLACEBO
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection
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
Sites / Locations
- Hospital Clinico Universitario de ValladolidRecruiting
- Hospital Universitario Río Hortega.Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Treatment of quadruple eradication therapy with GASTRUS
Treatment of quadruple eradication therapy with PLACEBO
Arm Description
Outcomes
Primary Outcome Measures
Global score of gastrointestinal symptoms assessed according the GSRS scale
Secondary Outcome Measures
Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03150394
Brief Title
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
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
June 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr. Luis Fernandez
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment of quadruple eradication therapy with GASTRUS
Arm Type
Experimental
Arm Title
Treatment of quadruple eradication therapy with PLACEBO
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
GASTRUS
Intervention Description
Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment
Intervention Type
Other
Intervention Name(s)
PLACEBO
Intervention Description
Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment
Primary Outcome Measure Information:
Title
Global score of gastrointestinal symptoms assessed according the GSRS scale
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment
Time Frame
60 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Fernandez, PhD
Phone
+34607537815
Email
luisfernsal@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jesus Barrio, PhD
Email
jbarrioa95@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Fernandez Dr. Jesus Barrio
Organizational Affiliation
Managers study
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Clinico Universitario de Valladolid
City
Valladolid
ZIP/Postal Code
47003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Fernandez, PhD
Phone
+34607537815
Email
luisfernsal@gmail.com
Facility Name
Hospital Universitario Río Hortega.
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jesus Barrio, PhD
Email
jbarrioa95@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.
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