Helicobacter Pylori InfectionPhase 4NCT03299725
Bismuth Based Quadruple Therapy 10 Days in Children
A Phase 4 study testing colloidal bismuth sub-citrate in people with Helicobacter Pylori Infection, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
Trial 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 +… Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- colloidal bismuth sub-citrate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Nov 2017to Nov 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
Hôpital Universitaire Des Enfants Reine Fabiola
Brussels, 1020
Samy Cadranel, MDPhD, 003224773216, samy.cadranel@huderf.be
Samy Cadranel, MDPhD
About this study
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).
Read more
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
- Being tested
- colloidal bismuth sub-citrate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colloidal bismuth sub-citrateDrug
colloidal bismuth sub-citrate administered as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm | Experimental | Not described Receives: Drug: colloidal bismuth sub-citrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
13C-urea breath test
Ratio of 13C/12C, expressed as delta 13C in pro mil, and compared with PeeDee Belemnite calcium carbonate standard
Measured: Week 10
Secondary outcomes (5)
Incidence of treatment-emergent adverse event
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: Up to 10 weeks after start of study treatment
Adherence to the study treatment
Adherence reported by patient on a diary card and study drug accountability
Measured: week 2
Intestinal microbiome analysis
Qualitative description
Measured: Week 0
Intestinal microbiome analysis
Changes in the relative phylum-level abundance in the stools, based on 16S rRNA classification, between week 0 and week 10
Measured: Week 10
Effect of antimicrobial resistance on the success rate
Qualitative description
Measured: Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start24 Nov 2017
- Primary completionNov 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Fabiola Children's University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdallah Kanfaoui, MD, Study director, Queen Fabiola Children's University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299725
- Sponsor's protocol ID
- CBS-EAM 10d
- Status last verified
- Feb 2018
- First submitted
- 27 Sep 2017
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03299725
- Acronym / sponsor ID
- CBS-EAM 10d
- Conditions
- Helicobacter Pylori Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Queen Fabiola Children's University HospitalUniversity, hospital or other
- Study start
- 24 Nov 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment arm | Experimental | Drug: colloidal bismuth sub-citrate |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (13 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| colloidal bismuth sub-citratecolloidal bismuth sub-citrate administered as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole | Drug | Treatment arm |
Primary outcome
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
5 secondary outcomes
Incidence of treatment-emergent adverse event
Time frame: Up to 10 weeks after start of study treatment
Adherence to the study treatment
Time frame: week 2
Intestinal microbiome analysis
Time frame: Week 0
Intestinal microbiome analysis
Time frame: Week 10
Effect of antimicrobial resistance on the success rate
Time frame: Week 10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdallah Kanfaoui, MD study director
Queen Fabiola Children's University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing colloidal bismuth sub-citrate in people with Helicobacter Pylori Infection, run by Queen Fabiola Children's University Hospital at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samy Cadranel, MDPhD (0032 2 477 32 16, samy.cadranel@huderf.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13C-urea breath test (time frame: Week 10). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018.