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

NCT03165253 | Completed DMC

• 1 other identifier: 2011-10-08/03
• Study Type: interventional
• Target: 69
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori infection; Children; Synbiotic; Standard Triple Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The eradication therapy associated side effects

  14 days period during the treatment

Study Arms (2)

Synbiotic Group

ACTIVE COMPARATOR

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; Drug: Amoxicillin Oral Tablet; Drug: Clarithromycin Oral Tablet; Drug: Omeprazole

Standard Therapy Group

OTHER

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; Drug: Clarithromycin Oral Tablet; Drug: Omeprazole

Interventions

Bifidobacterium Animalis Oral Product DRUG

The synbiotic group will receive this product.

Also known as: Bifidobacterium lactis

Synbiotic Group

Amoxicillin Oral Tablet DRUG

50mg/kg/day B.I.D.

Also known as: Amoxicillin

Standard Therapy Group; Synbiotic Group

Clarithromycin Oral Tablet DRUG

15 mg/kg/day B.I.D.

Also known as: Clarithromycin

Standard Therapy Group; Synbiotic Group

Omeprazole DRUG

1 mg/kg/day

Also known as: Omeprazole Capsule

Standard Therapy Group; Synbiotic Group

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bulent Ecevit University: lead

Related Publications (4)

• 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.

  PMID: 22491499 BACKGROUND

• 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.

  PMID: 21558964 BACKGROUND

• 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.

  PMID: 16611267 RESULT

• 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.

  PMID: 28656129 DERIVED

MeSH Terms

Interventions

Amoxicillin; Clarithromycin; Omeprazole

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Officials

• Gonca H Ustundag, MD

  Associate professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 24, 2017
• Study Start: June 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: August 1, 2012
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share