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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Omeprazole
DrugOmeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Pylera (Bismuth subcitrate potassium, metronidazole, tetracycline) given in combination with omeprazole
DrugPylera® 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.
Pylori Duo
Dietary supplementPylori 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.
Placebo
Other interventionPlacebo 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Standard Quadruple Therapy + PlaceboPlacebo comparator 3 interventions
Group B: Standard Quadruple Therapy + Pylori DuoExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Gastrointestinal adverse effects associated with standard eradication therapy
Assessment of the effect of Pylori Duo on the management of gastrointestinal adverse effects associated with standard Helicobacter pylori eradication therapy. Gastrointestinal tolerability will be evaluated during the treatment period and follow-up.
Time frame
Up to 3 months after treatment initiationSecondary outcomes
1
Helicobacter pylori eradication rate
Eradication of H. pylori will be assessed by negative 13C-urea breath test performed 6 to 8 weeks after completion of Phase I treatment. Gastric biopsy may also be considered according to protocol-defined diagnostic assessment.
Time frame
6 to 8 weeks after completion of the 10-day treatment phase2
Recurrence of Helicobacter pylori infection
Recurrence of H. pylori infection will be evaluated during follow-up at 3 and 12 months after treatment based on post-treatment clinical assessment and protocol-defined follow-up procedures.
Time frame
3 months and 12 months after completion of treatment3
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
Gastrointestinal symptoms will be assessed using the 15-item Gastrointestinal Symptom Rating Scale. Each item is scored from 1, indicating no troublesome symptoms, to 7, indicating very troublesome symptoms. The overall score is calculated as the mean of the 15 item scores and ranges from 1 to 7. Higher scores indicate greater gastrointestinal symptom severity and therefore a worse outcome. Change from baseline will be evaluated during the follow-up period.
Time frame
Baseline and 3 months after treatment initiation4
Change from baseline in Short Form Nepean Dyspepsia Index total score
Gastrointestinal health-related quality of life will be assessed using the 10-item Short Form Nepean Dyspepsia Index. The total score ranges from 0 to 100. Higher scores indicate better gastrointestinal health-related quality of life and therefore a better outcome. Change from baseline will be evaluated during the follow-up period.
Time frame
Baseline and 3 months after treatment initiationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: