Usefulness of the probiotic 'Lactobacillus reuteri' in the therapy of habitual eradication of infection Helicobacter pylori,

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 - VALACT

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-000342-22-ES

Enrollment

Registered

2017-02-10

Start date

2017-04-04

Completion date

Unknown

Last updated

2019-01-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Helicobacter Pylori infection MedDRA version: 19.1 Level: LLT Classification code 10019377 Term: Helicobacter pylori infection System Organ Class: 100000004862

Interventions

Trade Name: Amoxicilina Pharmaceutical Form: Tablet INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 Current Sponsor code: VALACT-2017-01 Other descriptive name: VALACT-2017-01 Concentration u

Eligibility

Sex/Gender

All

Inclusion 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To know if supplementation with Gastrus (food supplement) vs Placebo is able of lowering the gastrointestinal adverse effects of quadruple eradication therapy determined by the GSRS gastrointestinal symptom scale in routine clinical practice.;Secondary Objective: To know if the supplementation with Gastrus diminishes the individual symptoms to individual way evaluated by the scale of gastrointestinal symptoms GSRS. To know if the supplementation with Gastrus improves the accomplishment of the quadruple therapy.;Primary end point(s): Global score of gastrointestinal symptoms assessed according the GSRS scale.;Timepoint(s) of evaluation of this end point: 30 days	—

Measure

Time frame

Main Objective: To know if supplementation with Gastrus (food supplement) vs Placebo is able of lowering the gastrointestinal adverse effects of quadruple eradication therapy determined by the GSRS gastrointestinal symptom scale in routine clinical practice.;Secondary Objective: To know if the supplementation with Gastrus diminishes the individual symptoms to individual way evaluated by the scale of gastrointestinal symptoms GSRS. To know if the supplementation with Gastrus improves the accomplishment of the quadruple therapy.;Primary end point(s): Global score of gastrointestinal symptoms assessed according the GSRS scale.;Timepoint(s) of evaluation of this end point: 30 days

—

Secondary

Measure	Time frame
Secondary end point(s): Score obtained from each individual gastrointestinal symptom evaluated according the GSRS scale. Percentage of patients completing treatment.;Timepoint(s) of evaluation of this end point: 60 days	—

Countries

Spain

Contacts

Public ContactDr. Jesus Barrio

Dr. Luis Fernández-Dr. Jesus Barrio

jbarrioa95@gmail.com

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026