Recurrence Rate Comparison Between Esomeprazole and Lansoprazole in Eradicating Helicobacter Pylori Infection Among Children

NCT05861687 | Completed Phase 2

• 1 other identifier: LB.02.01.XV.III.2.2.2/344/2022
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 2

Brief Summary

This study aims to compare the recurrence rates of Esomeprazole and Lansoprazole in triple combination therapy to eradicate H.pylori infection in children. The participants were divided into two groups, those who received Esomeprazole and those who received Lansoprazole

Conditions

Helicobacter Pylori Infection

Keywords

Helicobacter pylori; Triple therapy; Children; Esomeprazole; Lansoprazole

Outcome Measures

Primary Outcomes (1)

• Helicobacter pylori Stool Antigen Test

  The stool of the subjects will be assessed on day-15 after drug administration. A negative result indicates that patient is infection-free

  15 days

Secondary Outcomes (1)

• Helicobacter pylori Stool Antigen Test

  75 days

Study Arms (2)

Esomeprazole in combination with Amoxicillin and Clarithromycin

EXPERIMENTAL

Esomeprazole : once a day per oral; 0.4 mg/kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg

Drug: Esomeprazole; Drug: Amoxicillin; Drug: Clarithromycin

Lansoprazole in combination with Amoxicillin and Clarithromycin

ACTIVE COMPARATOR

Lansoprazole: once a day per oral; 15 mg if body weight \< 30 kg and 30 mg if body weight \> 30 kg Amoxicillin: thrice a day per oral; 25 mg/kg Clarithromycin: twice a day per-oral; 7.5 mg/kg

Drug: Lansoprazole; Drug: Amoxicillin; Drug: Clarithromycin

Interventions

Esomeprazole DRUG

Administered once a day per-oral (PO) with the dose of 0.4 mg/kg

Esomeprazole in combination with Amoxicillin and Clarithromycin

Lansoprazole DRUG

Administered once a day per-oral (PO) with the dose of 15 mg if individual's body mass was \<30 kg, and 30 mg if it was \>30 kg

Lansoprazole in combination with Amoxicillin and Clarithromycin

Amoxicillin DRUG

Administered thrice a day per-oral (PO) with the dose of 25 mg/kg

Esomeprazole in combination with Amoxicillin and Clarithromycin; Lansoprazole in combination with Amoxicillin and Clarithromycin

Clarithromycin DRUG

Administered twice a day per-oral with the dose of 7.5 mg/kg

Esomeprazole in combination with Amoxicillin and Clarithromycin; Lansoprazole in combination with Amoxicillin and Clarithromycin

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Subject has positive clinical symptoms (gastrointestinal pain, nausea, vomiting, hematemesis, or melena)
• Subject had been diagnosed with H.pylori infection prior to endoscopy and rapid urease testing

You may not qualify if:

• subject has a history of using antibiotics or non-steroidal anti-inflammatory medicines (NSAIDs) within 14 days prior to surgery
• subject has a concomitant systemic disease (e.g., renal failure, liver cirrhosis, cancer, etc.) that could theoretically affect the subject's response to treatment
• Incomplete triple pharmacologic treatment due to the subject's lack of medication adherence

Sponsors & Collaborators

• Finni Kollins: lead

Study Sites (2)

Universitas Sumatera Utara General Hospital

Medan, North Sumatera, 20124, Indonesia

Location

Haji Adam Malik General Hospital

Medan, North Sumatera, 20136, Indonesia

Location

Related Publications (29)

• Awuku YA, Simpong DL, Alhassan IK, Tuoyire DA, Afaa T, Adu P. Prevalence of helicobacter pylori infection among children living in a rural setting in Sub-Saharan Africa. BMC Public Health. 2017 Apr 24;17(1):360. doi: 10.1186/s12889-017-4274-z.

  PMID: 28438158 BACKGROUND

• Jafar S, Jalil A, Soheila N, Sirous S. Prevalence of helicobacter pylori infection in children, a population-based cross-sectional study in west iran. Iran J Pediatr. 2013 Feb;23(1):13-8.

  PMID: 23550042 BACKGROUND

• Allen SJ, Thomas JE, Alexander ND, Bailey R, Emerson PM. Flies and Helicobacter pylori infection. Arch Dis Child. 2004 Nov;89(11):1037-8. doi: 10.1136/adc.2003.045880.

  PMID: 15499059 BACKGROUND

• Mansour MM, Al Hadidi KhM, Omar MA. Helicobacter pylori and recurrent abdominal pain in children: is there any relation? Trop Gastroenterol. 2012 Jan-Mar;33(1):55-61. doi: 10.7869/tg.2012.9.

  PMID: 22803297 BACKGROUND

• Das BK, Kakkar S, Dixit VK, Kumar M, Nath G, Mishra OP. Helicobacter pylori infection and recurrent abdominal pain in children. J Trop Pediatr. 2003 Aug;49(4):250-2. doi: 10.1093/tropej/49.4.250.

  PMID: 12929890 BACKGROUND

• Quek SH. Recurrent abdominal pain in children: a clinical approach. Singapore Med J. 2015 Mar;56(3):125-8; quiz 132. doi: 10.11622/smedj.2015038.

  PMID: 25820843 BACKGROUND

• Jones NL, Koletzko S, Goodman K, Bontems P, Cadranel S, Casswall T, Czinn S, Gold BD, Guarner J, Elitsur Y, Homan M, Kalach N, Kori M, Madrazo A, Megraud F, Papadopoulou A, Rowland M; ESPGHAN, NASPGHAN. Joint ESPGHAN/NASPGHAN Guidelines for the Management of Helicobacter pylori in Children and Adolescents (Update 2016). J Pediatr Gastroenterol Nutr. 2017 Jun;64(6):991-1003. doi: 10.1097/MPG.0000000000001594.

  PMID: 28541262 BACKGROUND

• Urgesi R, Cianci R, Riccioni ME. Update on triple therapy for eradication of Helicobacter pylori: current status of the art. Clin Exp Gastroenterol. 2012;5:151-7. doi: 10.2147/CEG.S25416. Epub 2012 Sep 17.

  PMID: 23028235 BACKGROUND

• Sahara S, Sugimoto M, Uotani T, Ichikawa H, Yamade M, Iwaizumi M, Yamada T, Osawa S, Sugimoto K, Umemura K, Miyajima H, Furuta T. Twice-daily dosing of esomeprazole effectively inhibits acid secretion in CYP2C19 rapid metabolisers compared with twice-daily omeprazole, rabeprazole or lansoprazole. Aliment Pharmacol Ther. 2013 Nov;38(9):1129-37. doi: 10.1111/apt.12492. Epub 2013 Sep 16.

  PMID: 24099474 BACKGROUND

• Peterson WL. The role of antisecretory drugs in the treatment of Helicobacter pylori infection. Aliment Pharmacol Ther. 1997 Apr;11 Suppl 1:21-5. doi: 10.1046/j.1365-2036.11.s1.4.x.

  PMID: 9146787 BACKGROUND

• Ward RM, Kearns GL. Proton pump inhibitors in pediatrics : mechanism of action, pharmacokinetics, pharmacogenetics, and pharmacodynamics. Paediatr Drugs. 2013 Apr;15(2):119-31. doi: 10.1007/s40272-013-0012-x.

  PMID: 23512128 BACKGROUND

• Nishida T, Tsujii M, Tanimura H, Tsutsui S, Tsuji S, Takeda A, Inoue A, Fukui H, Yoshio T, Kishida O, Ogawa H, Oshita M, Kobayashi I, Zushi S, Ichiba M, Uenoyama N, Yasunaga Y, Ishihara R, Yura M, Komori M, Egawa S, Iijima H, Takehara T. Comparative study of esomeprazole and lansoprazole in triple therapy for eradication of Helicobacter pylori in Japan. World J Gastroenterol. 2014 Apr 21;20(15):4362-9. doi: 10.3748/wjg.v20.i15.4362.

  PMID: 24764674 BACKGROUND

• Niv Y. H pylori recurrence after successful eradication. World J Gastroenterol. 2008 Mar 14;14(10):1477-8. doi: 10.3748/wjg.14.1477.

  PMID: 18330934 BACKGROUND

• Halitim F, Vincent P, Michaud L, Kalach N, Guimber D, Boman F, Turck D, Gottrand F. High rate of Helicobacter pylori reinfection in children and adolescents. Helicobacter. 2006 Jun;11(3):168-72. doi: 10.1111/j.1523-5378.2006.00396.x.

  PMID: 16684264 BACKGROUND

• Ding Z, Zhao S, Gong S, Li Z, Mao M, Xu X, Zhou L. Prevalence and risk factors of Helicobacter pylori infection in asymptomatic Chinese children: a prospective, cross-sectional, population-based study. Aliment Pharmacol Ther. 2015 Oct;42(8):1019-26. doi: 10.1111/apt.13364. Epub 2015 Aug 14.

  PMID: 26271484 BACKGROUND

• Leal-Herrera Y, Torres J, Monath TP, Ramos I, Gomez A, Madrazo-de la Garza A, Dehesa-Violante M, Munoz O. High rates of recurrence and of transient reinfections of Helicobacter pylori in a population with high prevalence of infection. Am J Gastroenterol. 2003 Nov;98(11):2395-402. doi: 10.1111/j.1572-0241.2003.07708.x.

  PMID: 14638339 BACKGROUND

• Sheu BS, Kao AW, Cheng HC, Hunag SF, Chen TW, Lu CC, Wu JJ. Esomeprazole 40 mg twice daily in triple therapy and the efficacy of Helicobacter pylori eradication related to CYP2C19 metabolism. Aliment Pharmacol Ther. 2005 Feb 1;21(3):283-8. doi: 10.1111/j.1365-2036.2005.02281.x.

  PMID: 15691303 BACKGROUND

• Kawabata H, Habu Y, Tomioka H, Kutsumi H, Kobayashi M, Oyasu K, Hayakumo T, Mizuno S, Kiyota K, Nakajima M, Kimoto K, Inokuchi H, Kawai K. Effect of different proton pump inhibitors, differences in CYP2C19 genotype and antibiotic resistance on the eradication rate of Helicobacter pylori infection by a 1-week regimen of proton pump inhibitor, amoxicillin and clarithromycin. Aliment Pharmacol Ther. 2003 Jan;17(2):259-64. doi: 10.1046/j.1365-2036.2003.01406.x.

  PMID: 12534411 BACKGROUND

• Mainz D, Borner K, Koeppe P, Kotwas J, Lode H. Pharmacokinetics of lansoprazole, amoxicillin and clarithromycin after simultaneous and single administration. J Antimicrob Chemother. 2002 Nov;50(5):699-706. doi: 10.1093/jac/dkf172.

  PMID: 12407126 BACKGROUND

• Liou JM, Chen CC, Chang CM, Fang YJ, Bair MJ, Chen PY, Chang CY, Hsu YC, Chen MJ, Chen CC, Lee JY, Yang TH, Luo JC, Chen CY, Hsu WF, Chen YN, Wu JY, Lin JT, Lu TP, Chuang EY, El-Omar EM, Wu MS; Taiwan Gastrointestinal Disease and Helicobacter Consortium. Long-term changes of gut microbiota, antibiotic resistance, and metabolic parameters after Helicobacter pylori eradication: a multicentre, open-label, randomised trial. Lancet Infect Dis. 2019 Oct;19(10):1109-1120. doi: 10.1016/S1473-3099(19)30272-5.

  PMID: 31559966 BACKGROUND

• Perez-Cobas AE, Gosalbes MJ, Friedrichs A, Knecht H, Artacho A, Eismann K, Otto W, Rojo D, Bargiela R, von Bergen M, Neulinger SC, Daumer C, Heinsen FA, Latorre A, Barbas C, Seifert J, dos Santos VM, Ott SJ, Ferrer M, Moya A. Gut microbiota disturbance during antibiotic therapy: a multi-omic approach. Gut. 2013 Nov;62(11):1591-601. doi: 10.1136/gutjnl-2012-303184. Epub 2012 Dec 12.

  PMID: 23236009 BACKGROUND

• Katsuki H, Nakamura C, Arimori K, Fujiyama S, Nakano M. Genetic polymorphism of CYP2C19 and lansoprazole pharmacokinetics in Japanese subjects. Eur J Clin Pharmacol. 1997;52(5):391-6. doi: 10.1007/s002280050307.

  PMID: 9272410 BACKGROUND

• Wu L, Wang Z, Sun G, Peng L, Lu Z, Yan B, Huang K, Yang Y. Effects of anti-H. pylori triple therapy and a probiotic complex on intestinal microbiota in duodenal ulcer. Sci Rep. 2019 Sep 6;9(1):12874. doi: 10.1038/s41598-019-49415-3.

  PMID: 31492912 BACKGROUND

• Park SK, Park DI, Choi JS, Kang MS, Park JH, Kim HJ, Cho YK, Sohn CI, Jeon WK, Kim BI. The effect of probiotics on Helicobacter pylori eradication. Hepatogastroenterology. 2007 Oct-Nov;54(79):2032-6.

  PMID: 18251154 BACKGROUND

• Dai C, Zheng CQ, Jiang M. Efficacy of probiotics in Helicobacter pylori eradication therapy. J Clin Gastroenterol. 2013 Oct;47(9):814-5. doi: 10.1097/MCG.0b013e318298a32c. No abstract available.

  PMID: 23751838 BACKGROUND

• Lynch SV, Pedersen O. The Human Intestinal Microbiome in Health and Disease. N Engl J Med. 2016 Dec 15;375(24):2369-2379. doi: 10.1056/NEJMra1600266. No abstract available.

  PMID: 27974040 BACKGROUND

• Gisbert JP, Pajares JM. Stool antigen test for the diagnosis of Helicobacter pylori infection: a systematic review. Helicobacter. 2004 Aug;9(4):347-68. doi: 10.1111/j.1083-4389.2004.00235.x.

  PMID: 15270750 BACKGROUND

• Vaira D, Malfertheiner P, Megraud F, Axon AT, Deltenre M, Hirschl AM, Gasbarrini G, O'Morain C, Garcia JM, Quina M, Tytgat GN. Diagnosis of Helicobacter pylori infection with a new non-invasive antigen-based assay. HpSA European study group. Lancet. 1999 Jul 3;354(9172):30-3. doi: 10.1016/s0140-6736(98)08103-3.

  PMID: 10406362 BACKGROUND

• Yang HR. Updates on the Diagnosis of Helicobacter pylori Infection in Children: What Are the Differences between Adults and Children? Pediatr Gastroenterol Hepatol Nutr. 2016 Jun;19(2):96-103. doi: 10.5223/pghn.2016.19.2.96. Epub 2016 Jun 28.

  PMID: 27437185 BACKGROUND

MeSH Terms

Interventions

Esomeprazole; Lansoprazole; Amoxicillin; Clarithromycin

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Erythromycin; Macrolides; Polyketides; Lactones

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Resident Doctor

Study Record Dates

• First Submitted: May 6, 2023
• First Posted: May 17, 2023
• Study Start: August 1, 2021
• Primary Completion: December 7, 2021
• Study Completion: May 20, 2022
• Last Updated: May 17, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ID (2)