Study on efficacy and tolerabilty of a 10 days adjunctive therapy with colloidal bismuth subcitrate to a standard triple therapy combining esomeprazole, , amoxicillin and metronidazole for eradicating Helicobacter Pylori in childre

Phase 1

• Conditions: Helicobacter pylory infection; MedDRA version: 20.0Level: LLTClassification code 10019377Term: Helicobacter pylori infectionSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2013-003931-30-BE
• Lead Sponsor: Hôpital Universitaire Des Enfants Reine Fabiola

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-20
• Last Update Posted: 11 December 2017

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Paediatric subjects aged 6 to 17 years of either gender
• Body weight = 20kg
• H. pylori gastritis confirmed by positive histology and culture with antimicrobial susceptibility testing.
• Subject able to swallow tablets
• All girls of child-bearing potential must have a negative urine pregnancy test at Visit 1
• If sexually active, girls of child-bearing potential and boys whose partner is of child-bearing potential agree to use highly effective method of birth control during the trial.
• In the Investigator’s opinion, patient is willing and able to comply with all trial requirements specified in this protocol.
• Subjects (or their legally-acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study. Assent is also required of children capable of understanding the nature of the study (typically older than 11 years of age).

Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Female participant who is pregnant, lactating or planning pregnancy during the course of the trial.
• Have a history of significant renal or hepatic impairment.
• Have an erosive esophagitis or peptic ulcer disease in the gastric or the duodenal mucosa.
• Have received proton pump inhibitors within 2 weeks prior to first administration of study agent.
• Have received any antimicrobial agent within 4 weeks prior to first administration of study agent.
• Require routine use (= 2 times per week) of non steroidal anti-inflammatory drug (NSAID)
• Are under any immunosuppressive agent
• Are under oral or IV steroids
• Scheduled elective surgery or any procedures requiring general anaesthesia during the trial.
• Known allergies or a known hypersensitivity to any Study Drugs or their excipients.
• Contraindication for any of the Study Drugs
• Any condition that, in the opinion of the Investigator, would compromise the well-being of the subject or the study or prevent the subject fromm meeting or performing study requirements.
• Participants who are participating or have participated in another study involving an investigational product in the past 12 weeks.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: 1) To assess the safety of a combination of bismuth sub-citrate, esomeprazole, amoxicillin and metronidazole given for 10 days in children aged 6 to 17 years.<br>2) To assess patient’s adherence to a combination of bismuth sub-citrate, esomeprazole, amoxicillin and metronidazole given for 10 days in children aged 6 to 17 years<br>3) To assess the effect of antimicrobial resistance on the success rate of a combination of bismuth sub-citrate, esomeprazole, amoxicillin and metronidazole given for 10 days in children aged 6 to 17 years<br>4) Microbiome analysis;Main Objective: To assess the elimination rate of H. pylori infection in children aged 6 to 17 years using a combination of bismuth sub-citrate, esomeprazole, amoxicillin and metronidazole given for 10 days;Primary end point(s): 13C-urea breath test ;Timepoint(s) of evaluation of this end point: Week 10

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): 1) Reporting of Adverse Event and Serious Adverse Event<br>2) Patient compliance based on patient diary card and study drug accountability<br>3) 13C-urea breath test & Antimicrobial susceptibility testing<br>4) Stool sampling;Timepoint(s) of evaluation of this end point: 1) Safety reporting throughout the study (Visit Week 0 to Visit Week 10)<br>2) Visit Week 2<br>3) Visit Week 10<br>4) Visit Week 0 & Visit Week 10