Helicobacter Pylori Infection
Conditions
Keywords
Helicobacter pylori infection, Children, Synbiotic, Standard Triple Therapy
Brief 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.
Interventions
DRUGBifidobacterium Animalis Oral Product
The synbiotic group will receive this product.
DRUGAmoxicillin Oral Tablet
50mg/kg/day B.I.D.
DRUGClarithromycin Oral Tablet
15 mg/kg/day B.I.D.
DRUGOmeprazole
1 mg/kg/day
Sponsors
Bulent Ecevit University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The eradication rates | 4-6 weeks after cessation of treatment | The eradication of H. pylori infection will be assessed by 14-carbon-urea breath test and the difference between eradication rates will be compared between the study groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The eradication therapy associated side effects | 14 days period during the treatment | Patients will be monitored at clinical visits and will be asked to recall for any side effects during the treatment protocol. |
Outcome results
None listed