Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection | NCT07729293

NCT07729293

Overview

NCT ID: NCT07729293
Lead Sponsor: Gala Servicios Clinicos S.L.OTHER
Official Title: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pylori Duo as an Adjunctive Treatment and for the Prevention of Recurrence of Helicobacter Pylori Infection
Brief Summary: 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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 27, 2026Actual
Start Date: Aug 31, 2026Estimated
Primary Completion Date: Oct 7, 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

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.

Exclusion Criteria:

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.

History of allergic reactions to medications included in the treatment regimen.

Use of bismuth-containing agents, antibiotics, proton pump inhibitors, or other relevant medications within 4 weeks prior to treatment.

Behaviors that may increase the risk of illness, including excessive alcohol consumption or substance abuse.

Negative repeat urea breath test prior to treatment initiation.

Unwillingness or inability to provide informed consent.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 140Estimated
Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Contacts and Locations

Central Contacts: Juan Antonio Carrillo, MedicineContact
carrillo@unex.es647725527 ext. +34

Similar Studies

Participant Group/Arms

Standard Quadruple Therapy + PlaceboPlacebo Comparator

Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days during Phase I, followed by placebo for 3 months during Phase II.

Drug: Omeprazole

Drug: Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole

Other: Placebo

Standard Quadruple Therapy + Pylori DuoExperimental

Participants assigned to this arm will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with Pylori Duo for 10 days during Phase I, followed by Pylori Duo for 3 months during Phase II.

Drug: Omeprazole