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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
Sponsor:
Information provided by (Responsible Party):
Queen Fabiola Children's University Hospital

Brief 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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment arm Drug: colloidal bismuth sub-citrate
colloidal bismuth sub-citrate administered as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. Adherence to the study treatment [ Time Frame: week 2 ]
    Adherence reported by patient on a diary card and study drug accountability

  3. Intestinal microbiome analysis [ Time Frame: Week 0 ]
    Qualitative description

  4. 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

  5. Effect of antimicrobial resistance on the success rate [ Time Frame: Week 10 ]
    Qualitative description



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Ages Eligible for Study:   6 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Paediatric subjects aged 6 to 17 years of either gender
  • Body weight ≥ 20kg.
  • Helicobacter pylori gastritis confirmed by positive histology and culture with antimicrobial susceptibility testing.
  • Antral and corpus biopsies must have been taken for histology and culture during an upper GI endoscopy performed for chronic or recurrent pain in the epigastric region with epigastric tenderness at physical examination.
  • 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.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the trial.
  • 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).

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 showed during the upper GI endoscopy.
  • 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
  • Have a scheduled elective surgery or any procedures requiring general anaesthesia during the trial.
  • Have known allergies or a known hypersensitivity to any Study Drugs or their excipients (refer to Study Drugs SmPCs).
  • Contraindication for any of the Study Drugs (refer to Study Drugs SmPCs).
  • Any condition that, in the opinion of the investigator, would compromise the well-being of the subject or the study or prevent the subject from meeting or performing study requirements.
  • Subjects who are participating or have participated in another study with an IMP in the past 12 weeks.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03299725


Contacts
Contact: Samy Cadranel, MDPhD 0032 2 477 32 16 samy.cadranel@huderf.be
Contact: Patrick Bontems, MDPhD 0032 2 477 32 16 patrick.bontems@huderf.be

Locations
Belgium
Hôpital Universitaire Des Enfants Reine Fabiola Recruiting
Brussels, Belgium, 1020
Contact: Samy Cadranel, MDPhD    003224773216    samy.cadranel@huderf.be   
Principal Investigator: Samy Cadranel, MDPhD         
Sponsors and Collaborators
Queen Fabiola Children's University Hospital
Investigators
Study Director: Abdallah Kanfaoui, MD Queen Fabiola Children's University Hospital

Responsible Party: Queen Fabiola Children's University Hospital
ClinicalTrials.gov Identifier: NCT03299725     History of Changes
Other Study ID Numbers: CBS-EAM 10d
First Posted: October 3, 2017    Key Record Dates
Last Update Posted: February 15, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Helicobacter Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Citric Acid
Amoxicillin
Metronidazole
Esomeprazole
Bismuth
Anticoagulants
Calcium Chelating Agents
Chelating Agents
Sequestering Agents
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Antacids