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The Role of Probiotics in the Eradication of Helicobacter Pylori

NCT04178187 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 660

Last updated 2022-03-25

No results posted yet for this study

Summary

All patients will receive quadruple eradication therapy for 10 days with Omerazole 20mg x2, Amoxicilin 1g x2, Clarithromycin 500mg x2 and Metronidazole 500mg x2. The patients will be randomised into two groups. The first group will receive one capsule of probiotics x2 two hours before or after meal for 15 days and the second group placebo (capsule with same composition and colour with probiotic) x2, two hours before or after meal for 15 days as well.

The probiotic (Lactolevure, Uni-Pharma, Athens) contains four probiotic strains known for their effectivness and safety, Saccharomyces Boulandrii (1.5 BU/capsule), Bifidobacterium Lactis BB-12 (1.75 BU/capsule), Lactobacillus Acidodophilus LA-5 (1.75 BU/capsule) and Lactobacillus Plantarum (0.5 BU/capsule).

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

Caps Lactolevure

One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.

DRUG

Caps Placebo

Caps Placebo

Sponsors & Collaborators

  • Evangelismos Hospital

    lead OTHER

Principal Investigators

  • Nikos Viazis, Dr · Evangelismos Hospital

  • Katerina Kotzampassi, MD · AHEPA University Hospital

  • Olga Giouleme, MD · General Hospital Of Thessaloniki Ippokratio

  • Periklis Apostolopoulos, MD · NIMTS Hospital

  • Sotirios Georgopoulos, MD · Iatriko Palaiou Falirou

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-10-02
Primary Completion
2021-12-31
Completion
2021-12-31

Countries

  • Greece

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178187 on ClinicalTrials.gov