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

Starting soon · Not applicable · Has a placebo group

Conditions studied: Helicobacter Pylori Infection, Dyspepsia, Gastrointestinal Adverse Effects

In brief

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.

Key facts

Study ID

NCT07729293

Run by

Gala Servicios Clinicos S.L.

People needed

140

Starts

2026-08-31

Expected to finish

2028-09-30

Last updated by the study team

2026-07-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GALA Laboratories — Don Benito, Badajoz, Spain

Full record on ClinicalTrials.gov

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