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Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial.
J Pediatr 2001; 139(5):664-8JPed

Abstract

OBJECTIVES

The aim of this multicenter prospective, randomized, double-blind study was to assess the efficacy of the combination of omeprazole, amoxicillin, and clarithromycin (OAC) for the treatment of Helicobacter pylori gastritis in children.

STUDY DESIGN

Seventy-three children with dyspeptic symptoms were included in the trial (mean age 10.8 years; range, 3.3 to 15.4). Patients were randomized to receive OAC or amoxicillin and clarithromycin (AC) for 7 days. H pylori status was assessed before and 4 weeks after eradication treatment, by use of the carbon 13-labeled urea breath test.

RESULTS

In intent-to-treat analysis (n = 63), eradication rates were 74.2% (95% CI, 58.7 to 89.6) in the OAC group and 9.4% (95% CI, 0 to 19.5) in the AC group. In per-protocol analysis (n = 53), the eradication rate increased to 80% (95% CI, 64.3 to 95.7), remaining significantly higher than in AC group (10.7%; 95% CI, 0 to 22.2). Resistance of strains to clarithromycin was rare (3/39 = 7.7%) and was not associated with failure of treatment. Adverse events were reported in 24.6% of patients and remained mild.

CONCLUSION

This study shows that 1-week OAC triple therapy results in successful eradication of H pylori in 75% of children with gastritis.

Authors+Show Affiliations

Department of Paediatrics, Jeanne de Flandre Hospital, Lille, France.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

11713443

Citation

Gottrand, F, et al. "Omeprazole Combined With Amoxicillin and Clarithromycin in the Eradication of Helicobacter Pylori in Children With Gastritis: a Prospective Randomized Double-blind Trial." The Journal of Pediatrics, vol. 139, no. 5, 2001, pp. 664-8.
Gottrand F, Kalach N, Spyckerelle C, et al. Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial. J Pediatr. 2001;139(5):664-8.
Gottrand, F., Kalach, N., Spyckerelle, C., Guimber, D., Mougenot, J. F., Tounian, P., ... Barthélemy, P. (2001). Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial. The Journal of Pediatrics, 139(5), pp. 664-8.
Gottrand F, et al. Omeprazole Combined With Amoxicillin and Clarithromycin in the Eradication of Helicobacter Pylori in Children With Gastritis: a Prospective Randomized Double-blind Trial. J Pediatr. 2001;139(5):664-8. PubMed PMID: 11713443.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial. AU - Gottrand,F, AU - Kalach,N, AU - Spyckerelle,C, AU - Guimber,D, AU - Mougenot,J F, AU - Tounian,P, AU - Lenaerts,C, AU - Roquelaure,B, AU - Lachaux,A, AU - Morali,A, AU - Dupont,C, AU - Maurage,C, AU - Husson,M O, AU - Barthélemy,P, PY - 2001/11/20/pubmed PY - 2002/1/5/medline PY - 2001/11/20/entrez SP - 664 EP - 8 JF - The Journal of pediatrics JO - J. Pediatr. VL - 139 IS - 5 N2 - OBJECTIVES: The aim of this multicenter prospective, randomized, double-blind study was to assess the efficacy of the combination of omeprazole, amoxicillin, and clarithromycin (OAC) for the treatment of Helicobacter pylori gastritis in children. STUDY DESIGN: Seventy-three children with dyspeptic symptoms were included in the trial (mean age 10.8 years; range, 3.3 to 15.4). Patients were randomized to receive OAC or amoxicillin and clarithromycin (AC) for 7 days. H pylori status was assessed before and 4 weeks after eradication treatment, by use of the carbon 13-labeled urea breath test. RESULTS: In intent-to-treat analysis (n = 63), eradication rates were 74.2% (95% CI, 58.7 to 89.6) in the OAC group and 9.4% (95% CI, 0 to 19.5) in the AC group. In per-protocol analysis (n = 53), the eradication rate increased to 80% (95% CI, 64.3 to 95.7), remaining significantly higher than in AC group (10.7%; 95% CI, 0 to 22.2). Resistance of strains to clarithromycin was rare (3/39 = 7.7%) and was not associated with failure of treatment. Adverse events were reported in 24.6% of patients and remained mild. CONCLUSION: This study shows that 1-week OAC triple therapy results in successful eradication of H pylori in 75% of children with gastritis. SN - 0022-3476 UR - https://www.unboundmedicine.com/medline/citation/11713443/Omeprazole_combined_with_amoxicillin_and_clarithromycin_in_the_eradication_of_Helicobacter_pylori_in_children_with_gastritis:_A_prospective_randomized_double_blind_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0022-3476(01)73701-8 DB - PRIME DP - Unbound Medicine ER -