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

24 de julho de 2026 atualizado 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

140

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Juan Antonio Carrillo, Medicine
  • Número de telefone: +34 647725527
  • E-mail: carrillo@unex.es

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de 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.
Medicamento: Omeprazole
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Medicamento: 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.
Outro: 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.
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.
Medicamento: Omeprazole
Omeprazole will be administered as part of the standard quadruple eradication therapy for Helicobacter pylori infection during the 10-day treatment phase.
Medicamento: 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.
Suplemento dietético: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Gastrointestinal adverse effects associated with standard eradication therapy
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Helicobacter pylori eradication rate
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Gala Servicios Clinicos S.L.

Investigadores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

31 de agosto de 2026

Conclusão Primária (Estimado)

7 de outubro de 2027

Conclusão do estudo (Estimado)

30 de setembro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

16 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

24 de julho de 2026

Primeira postagem (Real)

27 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

24 de julho de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 20260836

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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