Clinical Evaluation of a 14day Modified Bismuth Quadruple Therapy for the Eradication of Helicobacter Pylori in a High Clarithromycin and Metronidazole Resistance Area Regarding Patients With Peptic Ulcer and Non Ulcer Dyspepsia

Phase 4Not Yet RecruitingNCT07146594

Athens Medical Center150 enrolled

Overview

The goal of this clinical trial is to learn if a modified bismuth-containing therapy for the treatment of helicobacter pylori infection works to treat chronic helicobacter pylori related gastritis in adults treated either for first time or after a previous failure of another helicbacter erdication therapy. It will also learn about the safety and compliance of the modified bismuth containing therapy for helicobacter pylori. The main questions it aims to answer are: Does the modified bismuth-containing therapy for helicobacter pylori maintains a high eradication profile? What medical problems do participants have when taking the bismuth containing therapy? Researchers will present the eradication percentage of the modified bismuth containing therapy for helicobacter pylori in a difficult to treat population with a high profile of resistance to antibiotics for the treatment of helicobacter pylori separately for first time treated patients or patients with previous failures of other therapies. Participants will: Take the modified bismuth containing therapy which consists of four different medications (esomeprazole, amoxicillin, metronidazole, bismuth subcitrate) taken for 14 days in selected timepoints. Visit the clinic at the end of therapy for checkups and at 6 to 8 weeks after the end of therapy for final evaluation of completed eradication. Keep a diary of their symptoms and the number of medications taken.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

150

Conditions

Helicobacter Pylori Gastritis

Interventions

Modified bismuth-containing eradication treatmentDRUG

After the confirmation of Helicobacter pylori infection, eligible patients whether first line or rescue therapy will be assigned to receive: \- A modified and optimized bismuth quadruple therapy that comprises: 40 mg of esomeprazole bid, amoxicillin 1g tds, metronidazole 500mg tds and bismuth subcitrate 240mg bid, all medications taken for 14 days. Esomeprazole will be given at least 30 minutes before meals every 12 hours. Antibiotics will be given after meals every 8 hours and bismuth subcitrate at least 2 hours far from meals every 12 hours.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients of 18 years or older with dyspepsia or iron deficiency anaemia, referring for upper GI endoscopy and found to be infected with Helicobacter pylori (positive rapid urease test or histology), naïve or experienced to H. pylori eradication treatment, will be invited to participate in the study. Exclusion Criteria: * Exclusion criteria are: age below 18 years, presence of severe co-morbidities (i.e. liver cirrhosis, renal failure, haematological, neurological, psychiatric, severe cardiovascular or pulmonary disease), previous gastric surgery, gastric malignancies, Zollinger-Elisson syndrome, known allergy or other contraindications to the study medications, previous H. pylori bismuth containing therapies, use of antibiotics , bismuth salts , NSAIDS or aspirin in the preceding month, use of PPI in the preceding two weeks and not willing to participate in the study. Pregnant or lactating women will also be excluded.

Outcomes

Primary Outcomes

Effectiveness to eradicate helicobacter pylori with modified bismuth-containing treatment

Participants achieved helicobacter pylori eradication if they perform negative at 13C-urea breath test (13C-UBT) 6-8 weeks after completion of modified bismuth-containing treatment

Time frame: From enrollment to the end of treatment and assessment of eradication results at 8-10 weeks

Secondary Outcomes

Secondary outcomes are to assess patient's compliance and adverse events

Side effects of treatment will be assessed on a structured clinical interview with a specific questionnaire completed immediately after the end of eradication therapy and at the final re-evaluation at 8 weeks. During the interview, patients will be asked to grade the severity of each adverse event experienced as "mild" (transient and well tolerated), "moderate" (causing discomfort and partially interfering with common everyday activities), or "severe" (causing considerable interference with patients' daily activities). Incapacitating or life-threatening complications will be classified as serious and will be reported to regulatory agency (National Organization of Medicines). Adherence to treatment will be assessed by providing all patients with a pre-structured printed table with all dosages illustrated, asking to tick each time a pill was consumed and bring it back along with any tablet not consumed, for pill counting.

Time frame: From enrollment to the end of evaluation at 8 weeks