Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorGala Servicios Clinicos S.L.
About this trial
This randomized, double-blind, placebo-controlled, single-center clinical trial will evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 participants will be randomized to receive standard quadruple therapy (omeprazole plus Pylera®) combined with either placebo or Pylori Duo for 10 days, followed by placebo or Pylori Duo for 3 months. The primary objective is to assess the effect of Pylori Duo on gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include assessment of H. pylori eradication, recurrence at 3 and 12 months, gastrointestinal symptoms, quality of life, and safety.
Eligibility criteria
Qualifiers
Adults aged 18 to 70 years.
Confirmed Helicobacter pylori infection prior to treatment, as determined by a positive 13C-urea breath test (13C-UBT) and gastric biopsy.
No previous H. pylori eradication therapy.
Ability and willingness to provide written informed consent.
Disqualifiers
Significant underlying conditions that, in the opinion of the treating physician, would preclude participation in the study, including hepatic insufficiency (aspartate aminotransferase or alanine aminotransferase >3 times the upper limit of normal), renal insufficiency (creatinine ≥2.0 mg/dL or glomerular filtration rate <50 mL/min), immunosuppression, malignant tumors, coronary heart disease or coronary artery stenosis ≥75%, thyroid disease, pulmonary disease, or any other serious medical condition.
Pregnancy, breastfeeding, or unwillingness to use contraception during the study.
Active gastrointestinal bleeding.
History of upper gastrointestinal tract surgery.
Trial design
Treatments tested in this trial
- Omeprazole
- Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
- Pylori Duo
- Placebo
Treatment groups
140 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov