Pylori Duo for Adjunctive Treatment and Prevention of Recurrence of Helicobacter Pylori Infection
24 de julio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
140
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Juan Antonio Carrillo, Medicine
- Número de teléfono: +34 647725527
- Correo electrónico: carrillo@unex.es
Ubicaciones de estudio
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Badajoz
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Don Benito, Badajoz, España, 06400
- GALA Laboratories
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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 de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: 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.
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Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
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.
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.
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Experimental: 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.
|
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
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.
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.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gastrointestinal adverse effects associated with standard eradication therapy
Periodo de tiempo: Up to 3 months after treatment initiation
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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.
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Up to 3 months after treatment initiation
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Helicobacter pylori eradication rate
Periodo de tiempo: 6 to 8 weeks after completion of the 10-day treatment phase
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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.
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6 to 8 weeks after completion of the 10-day treatment phase
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Recurrence of Helicobacter pylori infection
Periodo de tiempo: 3 months and 12 months after completion of treatment
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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.
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3 months and 12 months after completion of treatment
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Change from baseline in Gastrointestinal Symptom Rating Scale overall score
Periodo de tiempo: Baseline and 3 months after treatment initiation
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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.
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Baseline and 3 months after treatment initiation
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Change from baseline in Short Form Nepean Dyspepsia Index total score
Periodo de tiempo: Baseline and 3 months after treatment initiation
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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.
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Baseline and 3 months after treatment initiation
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Participants with adverse events
Periodo de tiempo: Up to 3 months after the first dose
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Number and percentage of participants who experience at least one adverse event during the assessment period.
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Up to 3 months after the first dose
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Participants with study product-related adverse events
Periodo de tiempo: Up to 3 months after the first dose
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Number and percentage of participants who experience at least one adverse event considered by the investigator to be related to the study product.
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Up to 3 months after the first dose
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Treatment adherence
Periodo de tiempo: Up to 3 months after the first dose
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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.
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Up to 3 months after the first dose
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Sergio Chamorro Benítez, Medicine, Hospital Parque Vegas Altas, Don Benito (Badajoz)
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
31 de agosto de 2026
Finalización primaria (Estimado)
7 de octubre de 2027
Finalización del estudio (Estimado)
30 de septiembre de 2028
Fechas de registro del estudio
Enviado por primera vez
16 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
24 de julio de 2026
Publicado por primera vez (Actual)
27 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Signos y Síntomas Digestivos
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Dispepsia
- 2-piridinilmetilsulfinilbenzimidazoles
- Sulfóxidos
- Compuestos de azufre
- Químicos orgánicos
- Piridina
- Compuestos heterocíclicos, 1 anillo
- Compuestos heterocíclicos
- Benzimidazoles
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Azoles
- Hidrocarburos
- Hidrocarburos, cíclico
- Hidrocarburos aromáticos policíclicos
- Hidrocarburos, aromáticos
- Compuestos policíclicos
- Imidazoles
- Naftacenos
- Tetraciclinas
- Nitroimidazoles
- Compuestos nitro
- Metronidazol
- Tetraciclina
- Omeprazol
Otros números de identificación del estudio
- 20260836
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Descripción del plan IPD
Individual participant data collected during the trial will not be made publicly available.
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .