Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
NOT YET RECRUITING
NCT07729293
NA

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

Sponsor: Gala Servicios Clinicos S.L.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-08-31

Completion Date

2028-09-30

Last Updated

2026-07-27

Healthy Volunteers

No

Interventions

DRUG

Omeprazole

Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.

DRUG

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

Pylera® will be administered in combination with omeprazole as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.

DIETARY_SUPPLEMENT

Pylori Duo

Pylori Duo is a dietary supplement containing Lactobacillus rhamnosus and dried licorice extract. Participants assigned to the experimental arm will receive Pylori Duo in combination with standard quadruple therapy for 10 days, followed by Pylori Duo for 3 months during the post-treatment phase.

OTHER

Placebo

Placebo capsules identical in appearance to Pylori Duo, but without pharmacologically active ingredients, will be administered in combination with standard quadruple therapy for 10 days, followed by placebo for 3 months during the post-treatment phase.

Locations (1)

GALA Laboratories

Don Benito, Badajoz, Spain