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

24 lipca 2026 zaktualizowane przez: Gala Servicios Clinicos S.L.

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

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.

Przegląd badań

Status

Jeszcze nie rekrutacja

Warunki

Interwencja / Leczenie

Szczegółowy opis

This is a randomized, double-blind, placebo-controlled, single-center interventional clinical trial designed to evaluate the efficacy and safety of Pylori Duo as an adjunctive treatment in adult patients with confirmed Helicobacter pylori infection. Approximately 140 patients aged 18 to 70 years with a positive 13C-urea breath test and gastric biopsy performed before study initiation will be enrolled.

Participants will be randomly assigned to one of two parallel treatment groups. Group A will receive standard quadruple therapy consisting of omeprazole plus Pylera® in combination with placebo for 10 days, followed by placebo for 3 months. Group B will receive the same standard quadruple therapy in combination with Pylori Duo for 10 days, followed by Pylori Duo for 3 months. Both investigators and participants will remain blinded to treatment allocation throughout the study.

The primary objective of the study is to evaluate the effect of Pylori Duo on the management of gastrointestinal adverse effects associated with standard eradication therapy. Secondary objectives include evaluation of H. pylori eradication rate, recurrence of infection at 3 and 12 months after treatment, gastrointestinal symptoms assessed using the Gastrointestinal Symptom Rating Scale (GSRS), gastrointestinal quality of life assessed using the Nepean Dyspepsia Index-Short Form (NDI-SF), and safety and tolerability. Safety assessments will include the recording of adverse events, evaluation of their potential relationship to the study product, and treatment adherence monitoring.

Participants will attend scheduled follow-up visits during treatment and post-treatment follow-up. A 13C-urea breath test will be performed 6 to 8 weeks after completion of Phase I treatment to assess eradication. Follow-up will continue for 3 months after treatment completion, and a telephone assessment will be conducted at 12 months to evaluate recurrence. Statistical analyses will be performed using both intention-to-treat and per-protocol populations.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

140

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

  • Nazwa: Juan Antonio Carrillo, Medicine
  • Numer telefonu: +34 647725527
  • E-mail: carrillo@unex.es

Lokalizacje studiów

  • Hiszpania
    • Badajoz
      • Don Benito, Badajoz, Hiszpania, 06400
        • GALA Laboratories

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Podwójnie

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Komparator placebo: Standard Quadruple Therapy + Placebo
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.
Lek: Omeprazole
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Lek: 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.
Inny: 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.
Eksperymentalny: Standard Quadruple Therapy + Pylori Duo
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.
Lek: Omeprazole
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Lek: 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.
Suplement diety: 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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Gastrointestinal adverse effects associated with standard eradication therapy
Ramy czasowe: Up to 3 months after treatment initiation
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.
Up to 3 months after treatment initiation

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Helicobacter pylori eradication rate
Ramy czasowe: 6 to 8 weeks after completion of the 10-day treatment phase
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.
6 to 8 weeks after completion of the 10-day treatment phase
Recurrence of Helicobacter pylori infection
Ramy czasowe: 3 months and 12 months after completion of treatment
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.
3 months and 12 months after completion of treatment
Change from baseline in Gastrointestinal Symptom Rating Scale overall score
Ramy czasowe: Baseline and 3 months after treatment initiation
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.
Baseline and 3 months after treatment initiation
Change from baseline in Short Form Nepean Dyspepsia Index total score
Ramy czasowe: Baseline and 3 months after treatment initiation
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.
Baseline and 3 months after treatment initiation
Participants with adverse events
Ramy czasowe: Up to 3 months after the first dose
Number and percentage of participants who experience at least one adverse event during the assessment period.
Up to 3 months after the first dose
Participants with study product-related adverse events
Ramy czasowe: Up to 3 months after the first dose
Number and percentage of participants who experience at least one adverse event considered by the investigator to be related to the study product.
Up to 3 months after the first dose
Treatment adherence
Ramy czasowe: Up to 3 months after the first dose
Treatment adherence will be reported as the percentage of prescribed study product doses taken. The percentage will be calculated as the number of doses taken divided by the number of doses prescribed, multiplied by 100. Higher percentages indicate greater treatment adherence.
Up to 3 months after the first dose

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Gala Servicios Clinicos S.L.

Śledczy

  • Główny śledczy: Sergio Chamorro Benítez, Medicine, Hospital Parque Vegas Altas, Don Benito (Badajoz)

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

31 sierpnia 2026

Zakończenie podstawowe (Szacowany)

7 października 2027

Ukończenie studiów (Szacowany)

30 września 2028

Daty rejestracji na studia

Pierwszy przesłany

16 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

24 lipca 2026

Pierwszy wysłany (Rzeczywisty)

27 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

27 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

24 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 20260836

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

Individual participant data collected during the trial will not be made publicly available.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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