Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-26 @ 12:05 AM
Study NCT ID:
NCT03150394
Status:
UNKNOWN
Last Update Posted:
2017-08-25
First Post:
2017-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
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.
Sponsor:
Dr. Luis Fernandez
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: