The Role of Probiotics in the Eradication of Helicobacter Pylori

Helicobacter Pylori Infection Clinical Trial

Official title:

The Role of Probiotics in the Eradication of Helicobacter Pylori

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178187
• Other study ID #: 444/23/07/2019
• Status: Completed
• Phase: N/A
• Start date: October 2, 2019
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: Evangelismos Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 660
• Est. completion date: December 31, 2021
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Helicobacter Pylori Infection

Intervention

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

Locations

Country	Name	City	State
Greece	Evangelismos Hospital	Athens	Attiki
Greece	NIMTS Hospital	Athens
Greece	Iatriko Palaiou Falirou	Palaió Fáliro
Greece	General Hospital of Thessaloniki Ippokratio	Thessaloníki
Greece	University General Hospital of Thessaloniki AHEPA	Thessaloníki

Sponsors (1)

Lead Sponsor	Collaborator
Evangelismos Hospital

Country where clinical trial is conducted

Greece, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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