The Role of Probiotics in the Eradication of Helicobacter Pylori

NCT ID: NCT04178187

Last Updated: 2022-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 660 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-02
• Study Completion Date: 2021-12-31

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).

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.

Conditions

Helicobacter Pylori Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lactolevure

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

Group Type: ACTIVE_COMPARATOR

Caps Lactolevure

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Caps Placebo

Intervention Type: DRUG

Caps Placebo

Interventions

Caps Lactolevure

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

Intervention Type: DRUG

Caps Placebo

Caps Placebo

Intervention Type: DRUG

Other Intervention Names

Probiotics

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Evangelismos Hospital

OTHER

Sponsor Role: lead

Responsible Party

Nikos Viazis

Consultant Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nikos Viazis, Dr

Role: PRINCIPAL_INVESTIGATOR

Evangelismos Hospital

Katerina Kotzampassi, MD

Role: PRINCIPAL_INVESTIGATOR

AHEPA University Hospital

Olga Giouleme, MD

Role: PRINCIPAL_INVESTIGATOR

General Hospital Of Thessaloniki Ippokratio

Periklis Apostolopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

NIMTS Hospital

Sotirios Georgopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Iatriko Palaiou Falirou

Locations

Evangelismos Hospital

Athens, Attica, Greece

NIMTS Hospital

Athens, , Greece

Iatriko Palaiou Falirou

Palaió Fáliro, , Greece

University General Hospital of Thessaloniki AHEPA

Thessaloniki, , Greece

General Hospital of Thessaloniki Ippokratio

Thessaloniki, , Greece

Countries

Greece

References

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.

Reference Type: RESULT

PMID: 25894405 (View on PubMed)

Other Identifiers

444/23/07/2019

Identifier Type: -

Identifier Source: org_study_id