NCT03150394

Study of the Usefulness of the Probiotic 'Lactobacillus Reuteri' in the Therapy of Quadruple Eradication of Helicobacter Pylori Infection in Usual Clinical Practice.

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Dr. Luis Fernandez · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
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

Timeline

• Start date: 2017-04-04
• Primary completion: 2018-06-01
• Completion: 2018-08-01
• First posted: 2017-05-12
• Last updated: 2017-08-25

Locations

2 sites across 1 country: Spain