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CompletedNCT03165253Updated May 24, 2017

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

An interventional study of Bifidobacterium Animalis Oral Product and Amoxicillin Oral Tablet in Helicobacter Pylori Infection, sponsored by Bulent Ecevit University. Completed. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2017-05-24.

Sponsored by Bulent Ecevit University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 11 months after the study started (first participant enrolled Jun 2011, registered May 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
69
Allocation
Randomized
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Helicobacter Pylori Infection

Keywords

  • Helicobacter pylori infection
  • Children
  • Synbiotic
  • Standard Triple Therapy
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In context

Lead sponsor

Bulent Ecevit University is the lead sponsor of 47 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
69 participants (actual)

Study arms

  • Active comparator
    Synbiotic Group

    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

  • Other
    Standard Therapy Group

    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

06

What researchers measure

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.

    Time frame: 4-6 weeks after cessation of treatment

Secondary outcomes

  1. 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.

    Time frame: 14 days period during the treatment

07

Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 22491499 ↗
  • 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. PubMed 21558964 ↗
  • 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. PubMed 16611267 ↗
  • 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. PubMed 28656129 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 24, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03165253
Lead sponsor
Bulent Ecevit University
Responsible party
Gonca Handan Ustundag (Associate Professor of Pediatrics, Bulent Ecevit University) — Principal investigator
First posted
May 24, 2017
Start date
Jun 2011
Primary completion
Jun 2012
Completion
Aug 2012
Last update
May 24, 2017

Study contacts

Gonca H Ustundag, MD
principal investigator · Associate professor

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Bifidobacterium animalis

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