NCT04178187

The Role of Probiotics in the Eradication of Helicobacter Pylori

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 660 (actual)
• Sponsor: Evangelismos Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
DRUG	Caps Lactolevure	One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.
DRUG	Caps Placebo	Caps Placebo

Timeline

• Start date: 2019-10-02
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2019-11-26
• Last updated: 2022-03-25

Locations

5 sites across 1 country: Greece