NCT04178187

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
660

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 2, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 8, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

2.2 years

First QC Date

November 8, 2019

Last Update Submit

March 24, 2022

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter PyloriProbioticsEradication treatment of H.PyloriAntibioticsProton pump inhibitorsSaccharomyces boulardiiBifidobacterium lactisLactobacillus acidophilusLactobacillus plantarum

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Lactolevure

ACTIVE COMPARATOR

Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Probiotics

Drug: Caps Lactolevure

Placebo

PLACEBO COMPARATOR

Patients will receive quadruple eradication therapy for Helicobacter Pylori infection with Amoxicillin, Clarithromycin, Metronidazole, Omeprazole and Placebo

Drug: Caps Placebo

Interventions

Caps LactolevureDRUG

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

Also known as: Probiotics
Lactolevure
Caps PlaceboDRUG

Caps Placebo

Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Established Helicobacter Pylori Infection

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Evangelismos Hospital

Athens, Attica, 10676, Greece

Location

NIMTS Hospital

Athens, 11521, Greece

Location

Iatriko Palaiou Falirou

Palaió Fáliro, 17562, Greece

Location

University General Hospital of Thessaloniki AHEPA

Thessaloniki, 54636, Greece

Location

General Hospital of Thessaloniki Ippokratio

Thessaloniki, 54642, Greece

Location

Related Publications (1)

  • 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.

    PMID: 25894405RESULT

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Gastroenterology

Study Record Dates

First Submitted

November 8, 2019

First Posted

November 26, 2019

Study Start

October 2, 2019

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

March 25, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

GR(5)