Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial.
OBJECTIVE
The currently recommended first-line eradication treatment of Helicobacter pylori in children is usually successful in about 75%. Recently, in adults, a novel 10-day sequential treatment has achieved an eradication rate of 95%. The aim of the study was to assess the H pylori eradication rate of the sequential treatment regimen compared with conventional triple therapy in children.


METHODS
Seventy-eight consecutive children with H pylori infection were randomized to receive either sequential treatment (omeprazole plus amoxicillin for 5 days, followed by omeprazole plus clarithromycin plus tinidazole for another 5 days) (n = 38; 15 boys [39.5%]; median age, 11.0 years [range, 3.3-16 years]) or triple therapy (omeprazole, amoxicillin, and metronidazole) for 1 week (n = 37; 15 boys [40.5%]; median age, 9.9 years [range, 4.3-16 years]). H pylori infection was based on 2 out of 3 positive tests results: 13C-urea breath test, rapid urease test, and histologic analysis. Eradication was assessed by 13C-urea breath test 8 weeks after therapy.


RESULTS
Seventy-four patients completed the study. H pylori eradication was achieved in 36 children receiving sequential treatment (97.3%; 95% confidence interval, 86.2-99.5) and 28 children receiving triple therapy (75.7%; 95% confidence interval, 59.8-86.7) (P < .02). Compliance with therapy was good (>95%) in all.


CONCLUSIONS
Our study shows, for the first time in children, that 10-day sequential treatment achieves a higher eradication rate than standard triple therapy, which is consistent with the results of adult studies.
Francavilla
Ruggiero
R
Department of Biomedicina dell'Età Evolutiva, Università degli Studi di Bari, Bari, Italy. rfrancavilla@libero.it
Lionetti
Elena
E
Castellaneta
Stefania Paola
SP
Magistà
Anna Maria
AM
Boscarelli
Giuseppe
G
Piscitelli
Domenico
D
Amoruso
Annacinzia
A
Di Leo
Alfredo
A
Miniello
Vito Leonardo
VL
Francavilla
Antonio
A
Cavallo
Luciano
L
Ierardi
Enzo
E
D000328:Adult; D000658:Amoxicillin / Q000008:administration & dosage*; D000900:Anti-Bacterial Agents / Q000008:administration & dosage*; D000890:Anti-Infective Agents / Q000008:administration & dosage; D000897:Anti-Ulcer Agents / Q000008:administration & dosage*; D000994:Antitrichomonal Agents / Q000008:administration & dosage; D002648:Child; D002675:Child, Preschool; D017291:Clarithromycin / Q000008:administration & dosage; 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; D008795:Metronidazole / Q000008:administration & dosage; D009853:Omeprazole / Q000008:administration & dosage*; D012074:Remission Induction; D014011:Tinidazole / Q000008:administration & dosage; D016896:Treatment Outcome
D000900:Anti-Bacterial Agents; D000890:Anti-Infective Agents; D000897:Anti-Ulcer Agents; D000994:Antitrichomonal Agents; D014011:Tinidazole; D008795:Metronidazole; D000658:Amoxicillin; D017291:Clarithromycin; D009853:Omeprazole