Clinical trial NCT04178187: The Role of Probiotics in the Eradication of Helicobacter Pylori
Official title: The Role of Probiotics in the Eradication of Helicobacter Pylori
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter Pylori
Probiotics
Eradication treatment of H.Pylori
Antibiotics
Proton pump inhibitors
Saccharomyces boulardii
Bifidobacterium lactis
Lactobacillus acidophilus
Lactobacillus plantarum
Lead sponsor: Evangelismos Hospital
Sponsor class: OTHER
First posted: 2019-11-26
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Prevention of antibiotic side effects
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Evangelismos Hospital
state: Attiki
city: Athens
country: Greece
facility: NIMTS Hospital
city: Palaió Fáliro
country: Greece
facility: Iatriko Palaiou Falirou
city: Thessaloníki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
city: Thessaloníki
country: Greece
facility: General Hospital of Thessaloniki Ippokratio
Study officials:
affiliation: Evangelismos Hospital
name: Nikos Viazis, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: AHEPA University Hospital
name: Katerina Kotzampassi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: General Hospital Of Thessaloniki Ippokratio
name: Olga Giouleme, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: NIMTS Hospital
name: Periklis Apostolopoulos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Iatriko Palaiou Falirou
name: Sotirios Georgopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.