The Role of Probiotics in the Eradication of Helicobacter Pylori

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).

Study Overview

• Status: Completed
• Conditions: Helicobacter Pylori Infection
• Intervention / Treatment: Drug: Caps Lactolevure; Drug: Caps Placebo

Detailed Description

Patients with H.Pylori infection establised after a uper GI endoscopy and gastric biopsy 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 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).

Patients will report in a specific questionnare the presence or absence of symptoms suggestive of side effects associated with the Abx administered (i.e flatulance, abdominal pain, diarrhoea, regurgitation, vomiting).

All patints will be subjected to urea breath test one month after the completion of treatment in order to verify HP eradication.

• Study Type: Interventional
• Enrollment (Actual): 660
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 11521
    • NIMTS Hospital
  • Palaió Fáliro, Greece, 17562
    • Iatriko Palaiou Falirou
  • Thessaloníki, Greece, 54636
    • University General Hospital of Thessaloniki AHEPA
  • Thessaloníki, Greece, 54642
    • General Hospital of Thessaloniki Ippokratio
  • Attiki
    • Athens, Attiki, Greece, 10676
      • Evangelismos Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Established Helicobacter Pylori Infection

Exclusion Criteria:

• Pregnancy
• Lactate
• Previous eradication therapy for HP.
• Course of antibiotics and/or probiotics one month prior to stydy entry
• Course of PPI's, H2- antagonst and antacids two weeks prior to study entry
• Known allergy to antibiotics that will be used in study
• Coronary disease, heart failure,malignancy,thyroid disease, pulmonary disease or other serious disease as per medical judgment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Lactolevure; Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Probiotics	Drug: Caps Lactolevure; One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.; Other Names: Probiotics
Placebo Comparator: Placebo; Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Placebo	Drug: Caps Placebo; Caps Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevention of antibiotic side effects	Primary prevention of Abx side effects as assessed by a questionnaire including all possible side effects (i.e. vomiting, diarrhea, flatulence etc) on a ten point Likert scale.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Evangelismos Hospital
• Investigators: Principal Investigator: Nikos Viazis, Dr, Evangelismos Hospital; Principal Investigator: Katerina Kotzampassi, MD, Ahepa University Hospital; Principal Investigator: Olga Giouleme, MD, General Hospital of Thessaloniki Ippokratio; Principal Investigator: Periklis Apostolopoulos, MD, NIMTS Hospital; Principal Investigator: Sotirios Georgopoulos, MD, Iatriko Palaiou Falirou

Publications and helpful links

General Publications

• Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: November 8, 2019
• First Submitted That Met QC Criteria: November 25, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): March 25, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; Antibiotics; Saccharomyces boulardii; Helicobacter Pylori; Lactobacillus plantarum; Proton pump inhibitors; Bifidobacterium lactis; Lactobacillus acidophilus; Eradication treatment of H.Pylori
• Other Study ID Numbers: 444/23/07/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No