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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Helicobacter Pylori Infection

Intervention / Treatment
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* Drug: Bifidobacterium Animalis Oral Product
* Drug: Amoxicillin Oral Tablet
* Drug: Clarithromycin Oral Tablet
* Drug: Omeprazole


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Synbiotic Group<br>The patients will be treated with the standard triple therapy that consists of amoxicillin oral tablet 50 mg/kg/d and clarithromycin oral tablet 15 mg/kg/d twice daily for 14 days, and omeprazole 1 mg/kg/d once daily for a month, and the synbiotic Bifidobacterium animalis oral product (5000000000 colony forming units/dose) plus inulin (900 mg) given a single dose for 14 days, concurrently. | Drug: Bifidobacterium Animalis Oral Product<br>* The synbiotic group will receive this product.<br>* Other names: Bifidobacterium lactis;Drug: Amoxicillin Oral Tablet<br>* 50mg/kg/day B.I.D.<br>* Other names: Amoxicillin;Drug: Clarithromycin Oral Tablet<br>* 15 mg/kg/day B.I.D.<br>* Other names: Clarithromycin;Drug: Omeprazole<br>* 1 mg/kg/day<br>* Other names: Omeprazole Capsule;|
| Other: Standard Therapy Group<br>The patients in this group will be treated with standard triple therapy only. The standard triple therapy consists of amoxicillin oral tablet 50 mg/kg/d and clarithromycin oral tablet 15 mg/kg/d twice daily for 14 days, and omeprazole 1 mg/kg/d once daily for a month. | Drug: Amoxicillin Oral Tablet<br>* 50mg/kg/day B.I.D.<br>* Other names: Amoxicillin;Drug: Clarithromycin Oral Tablet<br>* 15 mg/kg/day B.I.D.<br>* Other names: Clarithromycin;Drug: Omeprazole<br>* 1 mg/kg/day<br>* Other names: Omeprazole Capsule;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The eradication rates | 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. | 4-6 weeks after cessation of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The eradication therapy associated side effects | Patients will be monitored at clinical visits and will be asked to recall for any side effects during the treatment protocol. | 14 days period during the treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Helicobacter pylori infection, Children, Synbiotic, Standard Triple Therapy