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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:
They will be determined by the GSRS gastrointestinal symptom scale in routine clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment of quadruple eradication therapy with GASTRUS | Experimental |
| |
| Treatment of quadruple eradication therapy with PLACEBO | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GASTRUS | Dietary Supplement | Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Global score of gastrointestinal symptoms assessed according the GSRS scale | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment | 60 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luis Fernandez, PhD | Contact | +34607537815 | luisfernsal@gmail.com | |
| Jesus Barrio, PhD | Contact | jbarrioa95@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Fernandez Dr. Jesus Barrio | Managers study | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinico Universitario de Valladolid | Recruiting | Valladolid | 47003 | Spain |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 30, 2020 | |
| Reset | Sep 18, 2020 |
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| PLACEBO | Other | Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment |
|
| Hospital Universitario Río Hortega. | Recruiting | Valladolid | 47012 | Spain |
|
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 30, 2020 | Sep 18, 2020 |