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AzTrials

Helicobacter Pylori InfectionPhase 4NCT02635191

Tailored Therapy for Helicobacter Pylori in Children

A Phase 4 study testing Tailored Group and Standard group in people with Helicobacter Pylori Infection, run by Beijing Children's Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This study is designed to compare the eradication rates，safety and compliance of tailored therapy to those of standard triple therapy in children with H. pylori infection. The primary purpose is to compare the eradication rates of children with H. Read more about this study

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Helicobacter Pylori Infection
What is being tested?
Tailored Group and Standard group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteChina
Study dates
Mar 2014to Jul 2016
Phase
Phase 4
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 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Clinical diagnosis of H. pylori infection.
  • Presence of upper gastrointestinal symptoms.
  • Referred for upper endoscopy at Beijing Children's Hospital

Who cannot join

  • Presence of endoscopy contraindications
  • The administration of any drug that could influence the study results including proton pump inhibitors, H2-receptor blockers, bismuth salts and antibiotics within the previous four weeks;
  • Gastrointestinal malignancy;
  • Previous gastric or esophageal surgery;
  • Severe concomitant diseases
  • History of allergy to any of the study drugs;

Trial locations and contacts

1 site in 1 country.

Xiwei Xu, MD contact

861059616308

xuxiweibch@163.com

China1 site, 1 recruiting

  • Study site

    Beijing

    Recruiting

Other trials in China

About this study

Official title: Tailored Therapy Versus Standard Triple Therapy for Helicobacter Pylori Eradication in Children: A Randomized Trial

This study is designed to compare the eradication rates，safety and compliance of tailored therapy to those of standard triple therapy in children with H. pylori infection. The primary purpose is to compare the eradication rates of children with H. pylori infection treated with tailored therapy to those treated with standard triple therapy. The secondary purpose is to evaluate the safety, compliance and factors that might affect eradication rates.

Read the detailed description

Between March 2014 and March 2016, 200 children with upper gastrointestinal symptoms (4-18 years) and H. pylori infection will be recruited at Beijing Children Hospital.After the informed consents are obtained from the guardians, the children will be randomly classified into the two group: 10 days standard triple therapy (Omeprazole 0.8-1.0mg/kg.d,bid, Amoxicillin 30-50mg/kg.d bid， Clarithromycin 15-20mg/kg.d bid), or 10 days tailored therapy including one Proton Pump Inhibitor ( Rabeprazole 0.4-0.5mg/kg.d,bid. or Esomeprazole 0.8-1.0mg/kg.d,bid) and two antibiotics (Amoxicillin 30-50mg/kg.d bid, Clarithromycin 15-20mg/kg.d bid, Metronidazole15-20mg/kg.d bid) based on antibiotics susceptibility and cytochrome P450 isoenzyme 2C19 genotype. Eradication status will be reassessed in four weeks after treatment.

Being tested
Tailored Group, Standard group
Keywords
Helicobacter pylori, Therapy, Children

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Tailored GroupDrug

    Also called "Rabeprazole"" Pariet®", "Esomeprazole"" Nexium®", "Metronidazole""Yabao®", "Amoxicillin""Tongdamoxing®"

    All the patients who enrolled in this arm will be received endoscopy followed by biopsy for antimicrobial susceptibility testing and cytochrome P450 isoenzyme 2C19 genotype. 10 days tailored therapy will be given including one Proton Pump Inhibitor ( Rabeprazole0.4-0.5mg/kg.d,bid. or Esomeprazole0.8-1.0mg/kg.d,bid) and two antibiotics (Amoxicillin30-50mg/kg.d bid, Clarithromycin15-20mg/kg.d bid, Metronidazole15-20mg/kg.d bid ) based on the cytochrome P450 isoenzyme 2C19 genotype and the antimicrobial susceptibility.

  • Standard groupDrug

    Also called "Omeprazole"" LosecMUPS®", "Amoxicillin""Tongdamoxing®", "Clarithromycin""Klacid®"

    All the patients who enrolled in this arm will be treated by Omeprazole(0.8-1.0mg/kg.d,bid), Amoxicillin (30-50mg/kg.d bid)and Clarithromycin (15-20mg/kg.d bid) .

Study groups in NCT02635191
Study groupRoleWhat they receive
Tailored GroupExperimentalIn tailored therapy, medications will be adjusted according to the antimicrobial susceptibility testing (including Clarithromycin sensitivity) and cytochrome P450 isoenzyme 2C19 genotype. 10 days regimen will be prescribed.
Receives: Drug: Tailored Group
Standard groupActive comparatorIn standard triple therapy, children will be treated by Omeprazole(0.8-1.0mg/kg.d,bid), Amoxicillin (30-50mg/kg.d bid)and Clarithromycin (15-20mg/kg.d bid) for 10 days.
Receives: Drug: Standard group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Compare the eradication rates in each group

    The efficacy of H. pylori eradication between the standard triple therapy and tailored therapy based on the results of antimicrobial resistance(including Clarithromycin sensitivity) by using H. pylori culture and cytochrome P450 isoenzyme 2C19 genotype. Eradication status will be reassessed in one month after treatment.

    Measured: One month after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2015 (estimated)
  2. Study startMar 2014
  3. Primary completionMar 2016 (estimated)
  4. Study completionJul 2016 (estimated)

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02635191
Sponsor's protocol ID
BCH-HP-001
Status last verified
Nov 2015
First submitted
25 Nov 2015
Last updated
18 Dec 2015
Results posted
No
Data monitoring committee
Yes

Publications

  • Liu G, Xu X, He L, Ding Z, Gu Y, Zhang J, Zhou L. Primary antibiotic resistance of Helicobacter pylori isolated from Beijing children. Helicobacter. 2011 Oct;16(5):356-62. doi: 10.1111/j.1523-5378.2011.00856.x.

    PubMed 21923681

  • 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

  • Zhou L, Zhang J, Song Z, He L, Li Y, Qian J, Bai P, Xue Y, Wang Y, Lin S. Tailored versus Triple plus Bismuth or Concomitant Therapy as Initial Helicobacter pylori Treatment: A Randomized Trial. Helicobacter. 2016 Apr;21(2):91-9. doi: 10.1111/hel.12242. Epub 2015 Jun 23.

    PubMed 26104022

  • Seo JH, Woo HO, Youn HS, Rhee KH. Antibiotics resistance of Helicobacter pylori and treatment modalities in children with H. pylori infection. Korean J Pediatr. 2014 Feb;57(2):67-71. doi: 10.3345/kjp.2014.57.2.67. Epub 2014 Feb 24.

    PubMed 24678329

  • Homan M, Hojsak I, Kolacek S. Helicobacter pylori in pediatrics. Helicobacter. 2012 Sep;17 Suppl 1:43-8. doi: 10.1111/j.1523-5378.2012.00982.x.

    PubMed 22958155

  • Erdur B, Ozturk Y, Gurbuz ED, Yilmaz O. Comparison of sequential and standard therapy for Helicobacter pylori eradication in children and investigation of clarithromycin resistance. J Pediatr Gastroenterol Nutr. 2012 Nov;55(5):530-3. doi: 10.1097/MPG.0b013e3182575f9c.

    PubMed 22465935

  • Bontems P, Kalach N, Oderda G, Salame A, Muyshont L, Miendje DY, Raymond J, Cadranel S, Scaillon M. Sequential therapy versus tailored triple therapies for Helicobacter pylori infection in children. J Pediatr Gastroenterol Nutr. 2011 Dec;53(6):646-50. doi: 10.1097/MPG.0b013e318229c769.

    PubMed 21701406

  • Mehri N, Kambiz E, Ahmad K, Fatemeh F, Farzaneh M, Hossein FG, Fatemeh M. The efficacy of a 1-week triple therapy for eradication of Helicobacter pylori infection in children. Arab J Gastroenterol. 2011 Mar;12(1):37-9. doi: 10.1016/j.ajg.2011.01.011. Epub 2011 Feb 5.

    PubMed 21429454

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Tailored Group and Standard group in people with Helicobacter Pylori Infection, run by Beijing Children's Hospital at 1 site in China.

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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 18 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Xiwei Xu, MD (861059616308, xuxiweibch@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Compare the eradication rates in each group (time frame: One month after 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 NCT02635191, which also lists 9 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 18 Dec 2015.

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