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Bismuth Based Quadruple Therapy 10 Days in Children

NCT03299725 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2018-02-15

No results posted yet for this study

Summary

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.

Conditions

  • Helicobacter Pylori Infection

Interventions

DRUG

colloidal bismuth sub-citrate

colloidal bismuth sub-citrate administered as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole

Sponsors & Collaborators

  • Queen Fabiola Children's University Hospital

    lead OTHER

Principal Investigators

  • Abdallah Kanfaoui, MD · Queen Fabiola Children's University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-24
Primary Completion
2019-11-30
Completion
2019-11-30

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03299725 on ClinicalTrials.gov