NCT03165253

The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children

The Effects of the Synbiotic "Bifidobacterium Lactis B94 Plus Inulin" Addition on Standard Triple Therapy of Helicobacter Pylori Eradication in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Bulent Ecevit University · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to evaluate the effects of the synbiotic Bifidobacterium animalis ssp. lactis B94 plus inulin addition to the standard triple therapy on Helicobacter pylori infection eradication rates in children.

Detailed description

The study aims to evaluate the effects of the synbiotic Bifidobacterium animalis ssp. lactis B94 plus inulin addition to the standard triple therapy on the eradication rates of Helicobacter pylori (H. pylori) infection in children. The subjects are children between 6 to 16 years old who had biopsy proven H. pylori infection. The subjects will be randomly classified into two groups. The first group will receive the standard triple therapy consisting of amoxicillin oral tablet (50 mg/kg/day) + clarithromycin oral tablet (15 mg/kg/day) + omeprazole oral capsule (1mg/kg/day). The second group will receive the standard triple therapy and Bifidobacterium animalis ssp. lactis B94 (5000000000 colony forming units/dose) plus inulin (900 mg) containing sachet for 14 days, concurrently. Eradication will be determined by 14-Carbon-urea breath test 4-6 weeks after therapy discontinuation. The eradication rates, the occurrence of side effects and the alterations of initial symptoms will be compared between the groups.

Conditions

• Helicobacter Pylori Infection

Interventions

Type	Name	Description
DRUG	Bifidobacterium Animalis Oral Product	The synbiotic group will receive this product.
DRUG	Amoxicillin Oral Tablet	50mg/kg/day B.I.D.
DRUG	Clarithromycin Oral Tablet	15 mg/kg/day B.I.D.
DRUG	Omeprazole	1 mg/kg/day

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-06-01
• Completion: 2012-08-01
• First posted: 2017-05-24
• Last updated: 2017-05-24