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Enteral Nutrition and Colonization Resistance Through Microbiota Modulation in Critically Ill Patients (MICRON)

20 de julho de 2026 atualizado por: Andra-Elena Goicea, Iuliu Hatieganu University of Medicine and Pharmacy

Enteral Nutrition to Enhance Colonization Resistance Through Gut Microbiota Modulation in Critically Ill Patients: A Randomized Controlled Pilot Trial

The goal of this clinical trial is to learn whether enteral nutrition enriched with fiber can influence gut microbiota and improve resistance to colonization with multidrug-resistant bacteria in critically ill patients. The study will also evaluate the safety and clinical outcomes associated with fiber-enriched enteral nutrition.

The main questions it aims to answer are:

  • Does fiber-enriched enteral nutrition reduce the acquisition of colonization with multidrug-resistant bacteria during intensive care unit (ICU) hospitalization?
  • Does fiber-enriched enteral nutrition modify the composition and diversity of the intestinal microbiota?
  • Are there differences in clinical outcomes, including adverse events, between patients receiving fiber-enriched and non-fiber enteral nutrition?

Researchers will compare patients receiving fiber-enriched enteral nutrition with patients receiving standard enteral nutrition without added fiber to determine whether fiber supplementation influences gut microbiota and colonization resistance.

Participants will:

  • Receive enteral nutrition through a feeding tube according to their clinical needs.
  • Receive either a fiber-enriched enteral nutrition formula or a standard enteral nutrition formula.
  • Have stool samples collected during ICU hospitalization for analysis of intestinal microbiota and detection of multidrug-resistant bacteria.
  • Be monitored for clinical outcomes, infections, antibiotic exposure, and adverse events during their ICU stay and follow-up period.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

Critically ill patients frequently experience alterations of the intestinal microbiota due to factors such as severe illness, antibiotic exposure, and the ICU environment. These changes may contribute to loss of colonization resistance and increased susceptibility to acquisition of multidrug-resistant bacteria, which are associated with increased morbidity and mortality in critically ill populations.

Enteral nutrition is commonly used in ICU patients who are unable to meet their nutritional requirements orally. Beyond its role in providing calories and nutrients, enteral nutrition may influence intestinal barrier function and microbiota composition. Fiber-containing enteral formulas include nondigestible carbohydrates that may act as substrates for microbial fermentation and may promote the growth of beneficial bacterial populations and the production of short-chain fatty acids.

Previous studies have suggested that fiber supplementation during enteral nutrition may influence gut microbiota composition and clinical outcomes; however, results remain inconsistent, particularly in critically ill patients receiving broad-spectrum antibiotics. The potential effect of fiber-enriched enteral nutrition on acquisition of multidrug-resistant bacterial colonization has not been adequately investigated.

This clinical trial aims to evaluate whether modulation of the intestinal microbiota through fiber-enriched enteral nutrition may influence colonization resistance in critically ill patients. The study will provide preliminary data regarding microbiota changes associated with enteral nutrition strategies and their potential relationship with multidrug-resistant bacterial colonization. These findings may support the design of future larger clinical trials evaluating nutritional interventions as a strategy to preserve microbiome function and reduce ICU-associated complications.

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

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: Daniel Corneliu Leucuța
  • Número de telefone: +40-597256 int 2501
  • E-mail: dleucuta@umfcluj.ro

Locais de estudo

  • Romênia
      • Cluj-Napoca, Romênia
        • Emergency Military Clinical Hospital "Dr. Constantin Papilian" Cluj-Napoca
        • Contato:

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:

  • Patients with medical (non-surgical) conditions admitted to the ICU.
  • ICU admission within the previous 48 hours at the study site.
  • Initiation of enteral nutrition within the first 48 hours after ICU admission.
  • Written informed consent obtained for participation in the study.

Exclusion Criteria:

  • Surgical ICU patients.
  • Patients in whom enteral nutrition was not initiated within the first 48 hours after - ICU admission.
  • Patients with galactosemia.
  • Patients with major contraindications to enteral nutrition, including: intestinal obstruction, intestinal ischemia, intestinal perforation, severe hemodynamic instability, patients who refuse participation in the study.

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: Prevenção
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Fiber-Enriched Enteral Nutrition
Participants will receive an enteral nutrition formula containing dietary fiber according to the study protocol.
Suplemento dietético: Fibre-Enriched Enteral Nutrition
Participants will receive enteral nutrition administered through an enteral feeding tube according to their clinical nutritional requirements. The intervention consists of an enteral nutrition formula enriched with dietary fiber, including fermentable fibers with potential prebiotic effects, intended to modulate intestinal microbiota composition and function. It will be administered according to the study protocol and clinical care requirements of critically ill patients. The intervention will be initiated during intensive care unit hospitalization and continued according to patient tolerance and clinical indications. The type and amount of enteral nutrition administered will be documented throughout the study period.
Outros nomes:
  • enteral feeding
  • tube feeding
Comparador Ativo: Standard Enteral Nutrition Without Fiber
Participants will receive an enteral nutrition formula without added dietary fiber according to the study protocol.
Suplemento dietético: Standard Enteral Nutrition
Participants will receive enteral nutrition administered through an enteral feeding tube according to their clinical nutritional requirements. The comparator intervention consists of a standard enteral nutrition formula without added fiber. It will be administered according to the study protocol and clinical care requirements of critically ill patients. The type and amount of enteral nutrition administered will be documented throughout the study period.
Outros nomes:
  • enteral feeding
  • tube feeding

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of Participants With New Multidrug-Resistant Bacterial Colonization Between Days 5 and 7
Prazo: ICU days 5-7 after admission
Proportion of participants who acquire new colonization with multidrug-resistant bacteria (MDRB) during ICU hospitalization, assessed between study days 5 and 7. New colonization will be defined as detection of MDRB not present at baseline (day 0) based on microbiological surveillance samples.
ICU days 5-7 after admission

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Gut Microbiota Diversity and Composition
Prazo: From ICU admission (Day 1) to ICU days 5-7
Changes in intestinal microbiota diversity and composition between baseline and follow-up samples, assessed by microbiome analysis of stool samples.
From ICU admission (Day 1) to ICU days 5-7
Proportion of Participants With MDRO Colonization at Day 14 and 28
Prazo: Day 14 and 28 after ICU admission
Proportion of participants with MDRB colonization detected on surveillance microbiological samples among participants who continue receiving enteral nutrition.
Day 14 and 28 after ICU admission
Incidence of Nosocomial Infections
Prazo: From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
Incidence and type of nosocomial infections occurring during ICU hospitalization.
From ICU admission (Day 1) to hospital discharge or Day 28, whichever occurs first
Duration of Mechanical Ventilation and Ventilator-Free Days
Prazo: Day 28 after ICU admission
Duration of invasive mechanical ventilation and number of ventilator-free days during the first 28 days after ICU admission.
Day 28 after ICU admission
Duration of ICU and Hospital Stay
Prazo: ICU stay: From ICU admission through ICU discharge, an average of 28 days; Hospital stay: From hospital admission through hospital discharge, an average of 90 days.
Duration of intensive care unit stay and total hospital length of stay.
ICU stay: From ICU admission through ICU discharge, an average of 28 days; Hospital stay: From hospital admission through hospital discharge, an average of 90 days.
28-Day Mortality and In-Hospital Mortality
Prazo: 28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days.
All-cause mortality occurring within 28 days after ICU admission and during the index hospital admission.
28-Day Mortality: 28 days after ICU admission; In-Hospital Mortality: during the hospital stay, up to hospital discharge, up to 90 days.
Correlation Between Immunological and Inflammatory Profile Changes and MDRB Colonization or Microbiota Changes
Prazo: From ICU admission (Day 1) to Day 28 after ICU admission
Correlation between longitudinal changes in inflammatory and immunological markes, and changes in MDRB colonization status and intestinal microbiota composition. Biomarkers will include routine laboratory parameters (e.g., leukocyte differential count, C-reactive protein, fibrinogen, erythrocyte sedimentation rate, ferritin) and immunological markers (e.g., immunoglobulins IgA, IgG, IgM, IgE, complement C3 and C4), and will be reported using their respective standard clinical laboratory units. MDRB colonization will be assessed by microbiological culture and reported for ESBL-producing organisms, CRE, MRSA, VRE. Intestinal microbiota composition will be characterized by next-generation sequencing and reported using taxonomic relative abundance and diversity indices.
From ICU admission (Day 1) to Day 28 after ICU admission

Colaboradores e Investigadores

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

Patrocinador

Iuliu Hatieganu University of Medicine and Pharmacy

Investigadores

  • Cadeira de estudo: Constantin Bodolea, "Iuliu Hațieganu" University of Medicine and Pharmacy Cluj-Napoca

Publicações e links úteis

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Publicações Gerais

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)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de outubro de 2027

Conclusão do estudo (Estimado)

1 de dezembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

14 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de julho de 2026

Primeira postagem (Real)

22 de julho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

20 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

  • DEP227/25.06.2026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

Individual participant data will not be shared because the study involves a relatively small number of critically ill patients and includes detailed clinical and microbiological information that may present privacy and confidentiality risks. Data will be handled according to applicable ethical and data protection requirements.

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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