Helicobacter Pylori InfectionNCT03165253
The Effects of a Synbiotic Addition on Eradication Therapy of Helicobacter Pylori Infection in Children
A study testing Bifidobacterium Animalis Oral Product, Amoxicillin Oral Tablet and Clarithromycin Oral Tablet in people with Helicobacter Pylori Infection, run by Bulent Ecevit University.
Trial 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 more about this study
- Who is it for?
- Ages 6 to 16 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Bifidobacterium Animalis Oral Product, Amoxicillin Oral Tablet and Clarithromycin Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- No sites listed yet
- Study dates
- Jun 2011to Aug 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
Official title: The Effects of the Synbiotic "Bifidobacterium Lactis B94 Plus Inulin" Addition on Standard Triple Therapy of Helicobacter Pylori Eradication in Children
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.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Bifidobacterium Animalis Oral Product, Amoxicillin Oral Tablet, Clarithromycin Oral Tablet, Omeprazole
- Keywords
- Helicobacter pylori infection, Children, Synbiotic, Standard Triple Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium Animalis Oral ProductDrug
Also called Bifidobacterium lactis
The synbiotic group will receive this product.
Amoxicillin Oral TabletDrug
Also called Amoxicillin
50mg/kg/day B.I.D.
Clarithromycin Oral TabletDrug
Also called Clarithromycin
15 mg/kg/day B.I.D.
OmeprazoleDrug
Also called Omeprazole Capsule
1 mg/kg/day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Amoxicillin Oral Tablet; Drug: Clarithromycin Oral Tablet; Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 14 days period during the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2017
- Study startJun 2011
- Primary completionJun 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bulent Ecevit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gonca Handan Ustundag, Bulent Ecevit University
- Investigators
- Gonca H Ustundag, MD, Principal investigator, Associate professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03165253
- Sponsor's protocol ID
- 2011-10-08/03
- Status last verified
- May 2017
- First submitted
- 23 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 22491499Koletzko 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 21558964Gotteland 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 16611267Ustundag 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
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of the Synbiotic "Bifidobacterium Lactis B94 Plus Inulin" Addition on Standard Triple Therapy of Helicobacter Pylori Eradication in Children
- ClinicalTrials.gov ID
- NCT03165253
- Acronym / sponsor ID
- 2011-10-08/03
- Conditions
- Helicobacter Pylori Infection
- Keywords
- Helicobacter pylori infection, Children, Synbiotic, Standard Triple Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Bulent Ecevit UniversityUniversity, hospital or other
- Study start
- Jun 2011 (actual)
- Primary completion
- Jun 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 24 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Synbiotic Group | Active comparator | Drug: Bifidobacterium Animalis Oral Product, Drug: Amoxicillin Oral Tablet, Drug: Clarithromycin Oral Tablet, Drug: OmeprazoleThe 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. |
| Standard Therapy Group | Other | Drug: Amoxicillin Oral Tablet, Drug: Clarithromycin Oral Tablet, Drug: OmeprazoleThe 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. |
Who may qualify
- Ages
- 6 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bifidobacterium Animalis Oral ProductAlso: Bifidobacterium lactisThe synbiotic group will receive this product. | Drug | Synbiotic Group |
| Amoxicillin Oral TabletAlso: Amoxicillin50mg/kg/day B.I.D. | Drug | Standard Therapy Group, Synbiotic Group |
| Clarithromycin Oral TabletAlso: Clarithromycin15 mg/kg/day B.I.D. | Drug | Standard Therapy Group, Synbiotic Group |
| OmeprazoleAlso: Omeprazole Capsule1 mg/kg/day | Drug | Standard Therapy Group, Synbiotic Group |
Primary outcome
The eradication rates
Time frame: 4-6 weeks after cessation of treatment
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.
1 secondary outcome
The eradication therapy associated side effects
Time frame: 14 days period during the treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Background: PubMed 22491499Malfertheiner 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.
- Background: PubMed 21558964Koletzko 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 publication: PubMed 16611267Gotteland 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.
- Derived from this study: PubMed 28656129Ustundag 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gonca H Ustundag, MD principal investigator
Associate professor
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium Animalis Oral Product, Amoxicillin Oral Tablet and Clarithromycin Oral Tablet in people with Helicobacter Pylori Infection, run by Bulent Ecevit University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The eradication rates (time frame: 4-6 weeks after cessation of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03165253, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.