Clinical trial NCT03165253: 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
Overall status: COMPLETED
Phase: NA
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori infection
Children
Synbiotic
Standard Triple Therapy
Lead sponsor: Bulent Ecevit University
Sponsor class: OTHER
First posted: 2017-05-24
Enrollment: 69
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The eradication rates
timeFrame: 4-6 weeks after cessation of treatment
Secondary outcomes:
measure: The eradication therapy associated side effects
timeFrame: 14 days period during the treatment
Other outcomes:
Locations:
Study officials:
affiliation: Associate professor
name: Gonca H Ustundag, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.