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Improved efficacy of 10-Day sequential treatment for Helicobacter pylori eradication in children: a randomized trial
Ruggiero Francavilla1, Elena Lionetti, Stefania Paola Castellaneta
1Department of Biomedicina dell'Età Evolutiva, Università degli Studi di Bari, Bari, Italy. rfrancavilla@libero.it
Insights
A novel 10-day sequential treatment significantly improved Helicobacter pylori eradication rates in children compared to standard triple therapy. This approach offers a more effective option for pediatric H. pylori infection management.
Area of Science:
- Pediatric Gastroenterology
- Infectious Diseases
- Microbiology
Background:
- Standard first-line Helicobacter pylori eradication therapy in children has an approximate 75% success rate.
- Recent adult studies show a novel 10-day sequential treatment achieves a 95% eradication rate.
Purpose of the Study:
- To evaluate the efficacy of a 10-day sequential treatment regimen for H. pylori eradication in children.
- To compare the sequential treatment's eradication rate against conventional triple therapy in pediatric patients.
Main Methods:
- A randomized study involving 78 children with H. pylori infection.
- Participants received either 10-day sequential treatment (omeprazole, amoxicillin, clarithromycin, tinidazole) or 7-day triple therapy (omeprazole, amoxicillin, metronidazole).
- H. pylori infection was confirmed by multiple diagnostic tests, and eradication was assessed via 13C-urea breath test 8 weeks post-therapy.
Main Results:
- The sequential treatment achieved an H. pylori eradication rate of 97.3% (36/37).
- The triple therapy group achieved an eradication rate of 75.7% (28/37).
- The difference in eradication rates between the two groups was statistically significant (P < .02).
Conclusions:
- The 10-day sequential treatment demonstrated a significantly higher H. pylori eradication rate in children compared to standard triple therapy.
- These findings in pediatric patients align with successful outcomes observed in adult studies.
- Sequential treatment represents a more effective therapeutic option for pediatric H. pylori infections.
Background & Aims:
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.
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