Back to resultsThe Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children
Primary Purpose
Helicobacter Pylori Infection
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bifidobacterium Animalis Oral Product
Amoxicillin Oral Tablet
Clarithromycin Oral Tablet
Omeprazole
Sponsored by
About this trial
This is an interventional treatment trial for Helicobacter Pylori Infection focused on measuring Helicobacter pylori infection, Children, Synbiotic, Standard Triple Therapy
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
Synbiotic Group
Standard Therapy Group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03165253
Brief Title
The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children
Official Title
The Effects of the Synbiotic "Bifidobacterium Lactis B94 Plus Inulin" Addition on Standard Triple Therapy of Helicobacter Pylori Eradication in Children
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2011 (Actual)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
August 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bulent Ecevit University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Helicobacter Pylori Infection
Keywords
Helicobacter pylori infection, Children, Synbiotic, Standard Triple Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
69 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Synbiotic Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard Therapy Group
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Bifidobacterium Animalis Oral Product
Other Intervention Name(s)
Bifidobacterium lactis
Intervention Description
The synbiotic group will receive this product.
Intervention Type
Drug
Intervention Name(s)
Amoxicillin Oral Tablet
Other Intervention Name(s)
Amoxicillin
Intervention Description
50mg/kg/day B.I.D.
Intervention Type
Drug
Intervention Name(s)
Clarithromycin Oral Tablet
Other Intervention Name(s)
Clarithromycin
Intervention Description
15 mg/kg/day B.I.D.
Intervention Type
Drug
Intervention Name(s)
Omeprazole
Other Intervention Name(s)
Omeprazole Capsule
Intervention Description
1 mg/kg/day
Primary Outcome Measure Information:
Title
The eradication rates
Description
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.
Time Frame
4-6 weeks after cessation of treatment
Secondary Outcome Measure Information:
Title
The eradication therapy associated side effects
Description
Patients will be monitored at clinical visits and will be asked to recall for any side effects during the treatment protocol.
Time Frame
14 days period during the treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gonca H Ustundag, MD
Organizational Affiliation
Associate professor
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
22491499
Citation
Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.
Results Reference
background
PubMed Identifier
21558964
Citation
Koletzko S, Jones NL, Goodman KJ, Gold B, Rowland M, Cadranel S, Chong S, Colletti RB, Casswall T, Elitsur Y, Guarner J, Kalach N, Madrazo A, Megraud F, Oderda G; H pylori Working Groups of ESPGHAN and NASPGHAN. Evidence-based guidelines from ESPGHAN and NASPGHAN for Helicobacter pylori infection in children. J Pediatr Gastroenterol Nutr. 2011 Aug;53(2):230-43. doi: 10.1097/MPG.0b013e3182227e90.
Results Reference
background
PubMed Identifier
16611267
Citation
Gotteland M, Brunser O, Cruchet S. Systematic review: are probiotics useful in controlling gastric colonization by Helicobacter pylori? Aliment Pharmacol Ther. 2006 Apr 15;23(8):1077-86. doi: 10.1111/j.1365-2036.2006.02868.x.
Results Reference
result
PubMed Identifier
28656129
Citation
Ustundag GH, Altuntas H, Soysal YD, Kokturk F. The Effects of Synbiotic "Bifidobacterium lactis B94 plus Inulin" Addition on Standard Triple Therapy of Helicobacter pylori Eradication in Children. Can J Gastroenterol Hepatol. 2017;2017:8130596. doi: 10.1155/2017/8130596. Epub 2017 Jun 1.
Results Reference
derived
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The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children
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