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

Helicobacter Pylori Infection Clinical Trial

Official title:

Comparative Recurrence Rate Investigation of Esomeprazole Versus Lansoprazole in Triple-Combination Therapy to Eradicate Helicobacter Pylori Infection Among Pediatrics: Multicentre, Randomized, and Controlled Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05861687
• Other study ID #: LB.02.01.XV.III.2.2.2/344/2022
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: August 1, 2021
• Est. completion date: May 20, 2022

Study information

• Verified date: May 2023
• Source: Universitas Sumatera Utara
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

H. pylori eradication therapy is still contentious. A treatment that is uncomplicated, well-tolerated, and boasts an efficiency rate of more than 80% is recommended. PPIs are a type of acid-sensitive drug which is most beneficial in preventing the degradation of drugs in the stomach. In developing countries, Esomeprazole and Lansoprazole were mainly selected as a drug of choice. Major influential factors such as Esomeprazole's additional antioxidant ability, are comparable to vitamin C. This is due to its ability to scavenge Diphenyl Picrylhydrazyl (DPPH) free radicals at low concentrations. Lansoprazole also possess similar ability, albeit needs a slightly higher concentration to reach a similar effect. In terms of IC50 values, both drugs have a substantial advantage over vitamin C, earning them the title of 'potentially ideal' agents in the treatment algorithm. Furthermore, numerous studies mention that children better tolerate PPIs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 20, 2022
• Est. primary completion date: December 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Helicobacter Infections
• Helicobacter Pylori Infection
• Infections
• Recurrence

Intervention

Drug:
• Esomeprazole
Administered once a day per-oral (PO) with the dose of 0.4 mg/kg
• Lansoprazole
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
• Amoxicillin
Administered thrice a day per-oral (PO) with the dose of 25 mg/kg
• Clarithromycin
Administered twice a day per-oral with the dose of 7.5 mg/kg

Locations

Country	Name	City	State
Indonesia	Haji Adam Malik General Hospital	Medan	North Sumatera
Indonesia	Universitas Sumatera Utara General Hospital	Medan	North Sumatera

Sponsors (1)

Lead Sponsor	Collaborator
Finni Kollins

Country where clinical trial is conducted

Indonesia, 

References & Publications (29)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Antimicrob Chemother. 2003 Feb;51(2):477. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Helicobacter pylori Stool Antigen Test	The stool of the subjects will be analyzed on day-90 after drug administration to assess whether a reinfection is present. A negative result indicates that patient is infection-free	75 days