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

24 juli 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

140

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: Juan Antonio Carrillo, Medicine
  • Telefoonnummer: +34 647725527
  • E-mail: carrillo@unex.es

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Dubbele

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: 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.
Geneesmiddel: Omeprazole
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Geneesmiddel: 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.
Ander: 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.
Experimenteel: 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.
Geneesmiddel: Omeprazole
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Geneesmiddel: 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.
Voedingssupplement: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Gastrointestinal adverse effects associated with standard eradication therapy
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Helicobacter pylori eradication rate
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Gala Servicios Clinicos S.L.

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

31 augustus 2026

Primaire voltooiing (Geschat)

7 oktober 2027

Studie voltooiing (Geschat)

30 september 2028

Studieregistratiedata

Eerst ingediend

16 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

24 juli 2026

Eerst geplaatst (Werkelijk)

27 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

27 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

24 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 20260836

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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