Tailored Therapy for Helicobacter Pylori in Children

NCT02635191 | Unknown Phase 4 DMC

• 1 other identifier: BCH-HP-001
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Therapy; Children

Outcome Measures

Primary Outcomes (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.

  One month after treatment

Other Outcomes (1)

• Compare the adverse reactions in each group

  Three months

Study Arms (2)

Tailored Group

EXPERIMENTAL

In 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.

Drug: Tailored Group

Standard group

ACTIVE COMPARATOR

In 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.

Drug: Standard group

Interventions

Tailored Group DRUG

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.

Also known as: "Rabeprazole"" Pariet®", "Esomeprazole"" Nexium®", "Metronidazole""Yabao®", "Amoxicillin""Tongdamoxing®"

Tailored Group

Standard group DRUG

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) .

Also known as: "Omeprazole"" LosecMUPS®", "Amoxicillin""Tongdamoxing®", "Clarithromycin""Klacid®"

Standard group

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Beijing Children's Hospital: lead

Study Sites (1)

Unknown Facility

Beijing, China

RECRUITING

Related Publications (9)

• 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.

  PMID: 21923681 BACKGROUND

• 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

• 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.

  PMID: 26104022 BACKGROUND

• 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.

  PMID: 24678329 BACKGROUND

• 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.

  PMID: 22958155 BACKGROUND

• 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.

  PMID: 22465935 BACKGROUND

• 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.

  PMID: 21701406 BACKGROUND

• 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.

  PMID: 21429454 BACKGROUND

MeSH Terms

Interventions

Rabeprazole; Esomeprazole

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Omeprazole

Study Officials

• Xiwei Xu, MD

  Beijing Children's Hosipital of Capital Medical University,China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiwei Xu, MD

CONTACT

861059616308; xuxiweibch@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of Gastroenterology Department

Study Record Dates

• First Submitted: November 25, 2015
• First Posted: December 18, 2015
• Study Start: March 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: July 1, 2016
• Last Updated: December 18, 2015

Record last verified: 2015-11

Locations

CN (1)