Bismuth Based Quadruple Therapy 10 Days in Children
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|ClinicalTrials.gov Identifier: NCT03299725|
Recruitment Status : Recruiting
First Posted : October 3, 2017
Last Update Posted : February 15, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Helicobacter Pylori Infection||Drug: colloidal bismuth sub-citrate||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||November 24, 2017|
|Estimated Primary Completion Date :||November 2019|
|Estimated Study Completion Date :||November 2019|
|Experimental: Treatment arm||
Drug: colloidal bismuth sub-citrate
colloidal bismuth sub-citrate administered as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole
- 13C-urea breath test [ Time Frame: Week 10 ]Ratio of 13C/12C, expressed as delta 13C in pro mil, and compared with PeeDee Belemnite calcium carbonate standard
- Incidence of treatment-emergent adverse event [ Time Frame: Up to 10 weeks after start of study treatment ]Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
- Adherence to the study treatment [ Time Frame: week 2 ]Adherence reported by patient on a diary card and study drug accountability
- Intestinal microbiome analysis [ Time Frame: Week 0 ]Qualitative description
- Intestinal microbiome analysis [ Time Frame: Week 10 ]Changes in the relative phylum-level abundance in the stools, based on 16S rRNA classification, between week 0 and week 10
- Effect of antimicrobial resistance on the success rate [ Time Frame: Week 10 ]Qualitative description
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299725
|Contact: Samy Cadranel, MDPhD||0032 2 477 32 firstname.lastname@example.org|
|Contact: Patrick Bontems, MDPhD||0032 2 477 32 email@example.com|
|Hôpital Universitaire Des Enfants Reine Fabiola||Recruiting|
|Brussels, Belgium, 1020|
|Contact: Samy Cadranel, MDPhD 003224773216 firstname.lastname@example.org|
|Principal Investigator: Samy Cadranel, MDPhD|
|Study Director:||Abdallah Kanfaoui, MD||Queen Fabiola Children's University Hospital|