Omeprazole combined with amoxicillin and clarithromycin in the eradication of Helicobacter pylori in children with gastritis: A prospective randomized double-blind trial.
OBJECTIVE
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.


METHODS
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.


CONCLUSIONS
This study shows that 1-week OAC triple therapy results in successful eradication of H pylori in 75% of children with gastritis.
Gottrand
F
F
Department of Paediatrics, Jeanne de Flandre Hospital, Lille, France.
Kalach
N
N
Spyckerelle
C
C
Guimber
D
D
Mougenot
J F
JF
Tounian
P
P
Lenaerts
C
C
Roquelaure
B
B
Lachaux
A
A
Morali
A
A
Dupont
C
C
Maurage
C
C
Husson
M O
MO
Barthélemy
P
P
D000293:Adolescent; D000658:Amoxicillin / Q000627:therapeutic use*; D001944:Breath Tests; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005756:Gastritis / Q000188:drug therapy* / Q000382:microbiology*; D016481:Helicobacter Infections / Q000188:drug therapy*; D016480:Helicobacter pylori; D006801:Humans; D008297:Male; D009853:Omeprazole / Q000627:therapeutic use*; D011446:Prospective Studies; D016896:Treatment Outcome
D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole