Helicobacter Pylori Infection Clinical Trial
Official title:
A Prospective Open-label Study on Efficacy and Tolerability of Colloidal Bismuth Sub-citrate as Adjunctive Therapy to a Combination of Esomeprazole, Amoxicillin and Metronidazole for 10 Days for Helicobacter Pylori Elimination in Children
Helicobacter pylori infection causes chronic gastritis, peptic ulcer disease and is involved
in the development of gastric cancer.
Current accepted strategies to eliminate the infection in children are a 10 days sequential
treatment (proton pump inhibitor + amoxicillin 5 days followed by proton pump inhibitor +
metronidazole + clarithromycin 5 days) or a triple therapy 14 days (proton pump inhibitor +
amoxicillin + clarithromycin or metronidazole).
However, there is a concern due to the growing resistance of Helicobacter pylori strains to
antibiotics, especially clarithromycin, and the decreased efficacy of first line treatment
regimens to satisfactorily eliminate the infection in children.
Recent data show that combinations using bismuth salts must be considered in adults. Indeed,
the efficacy of a 10 days of quadruple therapy with omeprazole plus a single three-in-one
capsule containing bismuth subcitrate, metronidazole and tetracycline was shown to be highly
superior to the standard triple therapy combining omeprazole, amoxicillin, and clarithromycin
without related severe adverse events.
The possibility of re-using bismuth salts on a more regular basis in pediatrics is being
restudied through a monocentric, prospective, open label, single arm clinical trial to assess
the safety and efficacy of a 10 days colloidal bismuth sub-citrate as an adjunctive therapy
in combination with esomeprazole, amoxicillin and metronidazole in children aged 6-17 years,
infected by Helicobacter pylori.
n/a
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