Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- Global score of gastrointestinal symptoms assessed according the GSRS scale [30 days]
Secondary Outcome Measures
- Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment [60 days]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hospital Clinico Universitario de Valladolid | Valladolid | Spain | 47003 | |
| 2 | Hospital Universitario Río Hortega. | Valladolid | Spain | 47012 |
Sponsors and Collaborators
- Dr. Luis Fernandez
Investigators
- Study Director: Dr. Fernandez Dr. Jesus Barrio, Managers study
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- VALACT-2017-01