Tailored Therapy for Helicobacter Pylori in Children

Helicobacter Pylori Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02635191
• Other study ID #: BCH-HP-001
• Status: Recruiting
• Phase: Phase 4
• First received: November 25, 2015
• Last updated: December 16, 2015
• Start date: March 2014
• Est. completion date: July 2016

Study information

• Verified date: November 2015
• Source: Beijing Children's Hospital
• Contact: Xiwei Xu, MD
• Phone: 861059616308
• Email: xuxiweibch[@]163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Science and Technology
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 18 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of H. pylori infection.

• Presence of upper gastrointestinal symptoms.

• Referred for upper endoscopy at Beijing Children's Hospital

Exclusion Criteria:

• 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;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Helicobacter Infections
• Helicobacter Pylori Infection

Intervention

Drug:
• Tailored Group
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 group
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) .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Children's Hospital

Country where clinical trial is conducted

China, 

References & Publications (9)

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. — View Citation

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. Retraction in: Branski D, Heyman MB. J Pediatr Gastroenterol Nutr. 2013 Feb;56(2):239. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compare the adverse reactions in each group		Three months	No
Primary	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	No