Treatment of stomach infection with the bacteria H. pylori: comparisson of two exisiting treatments

Eradication of H. pylori infection in Belgium: bismuth versus first line therapy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000228-24-BE

Enrollment

250

Registered

2016-01-28

Start date

2016-07-13

Completion date

Unknown

Last updated

2024-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with H. pylori infection, never treated before

Interventions

Trade Name: Amoxicilline 1g Pharmaceutical Form: Tablet INN or Proposed INN: AMOXICILLIN CAS Number: 26787-78-0 Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- Trade

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Diagnosis of H. pylori gastritis based on histology and/or culture. Biopsies taken following the guidelines: 2 antral and 2 corpus biopsies Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 250 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 250

Exclusion criteria

Exclusion criteria: History of previous eradication, recent antibiotics use (8 weeks), no follow up possible (phone calls, e-mail), known allergy to one of the medication, age < 18 years , substantial organ impairment, undergone major surgery of the upper gastrointestinal tract, pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame
Main Objective: To compare 10 days of classical first line therapy versus 10 days of bismuth based therapy Triplera for the treatment of H. pylori infection.;Secondary Objective: Not applicable;Primary end point(s): Eradication of the H.pylori bacteria;Timepoint(s) of evaluation of this end point: 6 weeks after the start of the treatment	—

Secondary

Measure	Time frame
Secondary end point(s): A financial evaluation between the two treatments will be done, taking into account the drop out due to side effects and the costs for a second therapy in case of eradication failure. ;Timepoint(s) of evaluation of this end point: at the end of the study	—

Countries

Belgium

Contacts

Public ContactProfessor Mana

UZ Brussel

fazia.mana@uzbrussel.be0032024776011

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026