The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children
The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children
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.
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.
Inclusion Criteria:

 -  Children who are investigated by a standard esophagogastroduodenoscopy (EGD) for
 gastrointestinal symptoms those suggesting of an organic disease such as chronic
 abdominal pain, unexplained nausea and/or vomiting, severe regurgitation,
 gastrointestinal bleeding, unexplained weight loss, or chronic diarrhea and who are
 found to be H. pylori positive in gastric biopsies are included in the study.

 Exclusion Criteria:

 -  Patients who were treated for H. pylori infection previously, or who used an
 antimicrobial agent, bismuth, a non-steroid anti-inflammatory drug, or any form of
 gastric acid suppressor during the eight weeks prior to EGD, or who had history of
 major gastrointestinal surgery, chronic renal or hepatic disease and who were known to
 have drug allergy were excluded from the study.