Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

No Guts No Glory Probiotics (NGNGP)

18 de maio de 2026 atualizado por: University Medical Center Groningen

Probiotic Formulation to Prevent or Mitigate Antipsychotic Induced Metabolic Side-effects - A Multi-centre Randomized Placebo-controlled Double-blind Trial

The goal of this clinical trial is to learn if probiotics work to prevent or reduce metabolic side effects caused by antipsychotic medication in adults.

The main question it aims to answer is:

Do probiotics reduce weight gain, blood sugar levels, and blood fat levels in people using antipsychotics?

Researchers will compare a probiotic (Ecologic® Barrier) to a placebo (a look-alike powder without active bacteria) to see if the probiotic is effective.

Participants will:

Take either probiotics or a placebo daily for 12 weeks (3 months) Dissolve two sachets in water and drink them each morning Visit the clinic (or receive home visits) four times: at the start, after 6 weeks, and after 12 weeks, plus an initial screening visit Undergo physical measurements (e.g., weight, blood pressure), complete questionnaires, and perform a cognitive test at specific visits Provide blood samples and stool samples at the beginning and end of the study Complete two 3-day food diaries during the study

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

Antipsychotic medications such as olanzapine, quetiapine, clozapine, and risperidone are widely used for the treatment of psychotic and mood disorders. Although effective, these medications are frequently associated with adverse metabolic effects, including weight gain, increased blood glucose levels, and dyslipidemia. These side effects can negatively impact physical health and increase the risk of cardiovascular disease and diabetes.

Emerging evidence suggests that the gut microbiome may play a role in metabolic regulation and that modulation of gut microbiota through probiotics could mitigate antipsychotic-induced metabolic disturbances. Probiotics are live microorganisms that, when administered in adequate amounts, may confer health benefits by improving gut barrier function and influencing metabolic processes.

This study is a randomized, double-blind, placebo-controlled clinical trial designed to investigate the efficacy and safety of a multispecies probiotic formulation (Ecologic® Barrier) in preventing or reducing metabolic side effects in patients initiating treatment with antipsychotic medication. A total of 112 participants will be enrolled and randomly assigned to receive either the probiotic or a placebo for a duration of 12 weeks.

The investigational product consists of a powder formulation containing nine bacterial strains, administered as two sachets dissolved in water once daily in the morning. The placebo consists of an inert powder (e.g., maize starch and maltodextrin) with identical appearance and administration schedule. Participants, investigators, and study personnel will remain blinded to treatment allocation throughout the study.

Participants will continue their standard psychiatric treatment, including antipsychotic and/or mood-stabilizing medication, with minimal changes where possible. Concomitant use of additional psychotropic medications such as a second antipsychotic, lithium, or antiepileptic drugs is permitted.

Study procedures include baseline, interim (6 weeks), and end-of-study (12 weeks) assessments. These assessments involve physical measurements (e.g., body weight, waist and hip circumference, blood pressure), laboratory analyses of metabolic parameters using blood samples, and stool sample collection for microbiome-related analyses. In addition, participants will complete validated questionnaires assessing quality of life, eating behavior, and gastrointestinal symptoms, as well as cognitive testing at baseline and study completion.

Dietary intake will be monitored using two 3-day food diaries (pre-intervention and prior to the final visit) to account for potential dietary influences on metabolic outcomes and gut microbiota.

The primary objective is to evaluate whether probiotic supplementation reduces antipsychotic-induced metabolic disturbances compared to placebo. Secondary objectives include assessing safety and tolerability, as well as exploring changes in gastrointestinal symptoms, cognitive functioning, and potential microbiome-related mechanisms.

The total study duration per participant is approximately 3 months, with an additional optional one-month post-study probiotic use. After study completion, treatment allocation will be unblinded. Participants will be monitored throughout the study for adverse events, with particular attention to gastrointestinal symptoms, which are expected to be mild and transient.

This study aims to provide further evidence on the role of probiotics as a low-risk, adjunctive intervention to improve metabolic health in patients treated with antipsychotic medication.

Tipo de estudo

Intervencional

Inscrição (Estimado)

112

Estágio

  • Fase 2
  • Fase 3

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

Locais de estudo

  • Holanda
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Holanda, 8911KJ
        • Recrutamento
        • KieN VIP Leeuwarden
        • Contato:
          • Marrit Wiersma
          • Número de telefone: +31614734656
          • E-mail: marrit@kien.nu
        • Contato:
        • Investigador principal:
          • Nynke Boonstra, PhD
    • Provincie Groningen
      • Groningen, Provincie Groningen, Holanda, 9713GZ
        • Recrutamento
        • University Medical Center Groningen
        • Contato:
        • Investigador principal:
          • Iris E.C. Sommer, MD, PhD
    • South Holland
      • Rotterdam, South Holland, Holanda, 3083AK
        • Recrutamento
        • Antes Parnassia Groep
        • Contato:
        • Investigador principal:
          • Nico van Beveren, MD, PhD

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:

  1. About to start, or having started within the last 8 weeks, antipsychotic treatment with olanzapine, quetiapine*, clozapine or risperidone for treating psychosis
  2. Aged between 18 - 65
  3. No exposure to these four antipsychotic medications for longer than one week continuously in the last 6 months (except starting the treatment with the current medication 8 weeks prior to the inclusion)

  4. The participant understands the study and is able to provide written informed consent.

    • Quetiapine prescribed in a low dose for use as a sleep aid does not apply

Exclusion Criteria:

  1. Critically ill patients (e.g. ICU), diagnosed comorbid eating disorders, chronic GI-disorders, disorders of the liver or pancreas, pre-existing diagnosed diabetes mellitus or metabolic syndrome
  2. Current use of medications known to target metabolism or weight (e.g, diabetes medication and GLP-1 agonists, proton pump inhibitors and diuretics/beta blockers) or use of antibiotics or probiotics (such as Yakult, Activia, or other probiotic supplements containing ≥10⁹ CFUs) in the past 4 weeks
  3. Pregnancy or breastfeeding
  4. Inability to follow the intervention or other conditions that according to the investigator might interfere with the evaluation of the study objectives as judged by the treating physician

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 de grupo único
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: Probiotic intervention
This group uses a probiotic formulation to prevent metabolic risk factors of antipsychotics
Suplemento dietético: Probiotic Formula

After informed consent, participants will be randomized 1:1 to either:

  • Intervention group: Ecologic® Barrier
  • Control group: Placebo powder (identical in appearance, taste, and packaging but without active bacterial strains)

Ecologic® Barrier

  • Dosage form: Powder formulation containing a multi-strain probiotic mixture
  • Dosage: Standard manufacturer-recommended dose per sachet
  • Frequency: Twice daily (morning and evening)
  • Route of administration: Oral, dissolved in water or another non-carbonated beverage
  • Duration: 12 weeks (3 months)
  • Distinguishing characteristics:
  • Contains a defined combination of probiotic strains specifically formulated to support gut ba- rrier integrity
  • Delivered as a powder sachet to ensure stability of live bacterial cultures
  • Designed to modulate gut-brain axis pathways relevant to antipsychotic-associated metabolic effects
Outros nomes:
  • Ecologic Barrier
Comparador de Placebo: Placebo
This group uses a placebo
Suplemento dietético: Placebo
  • Dosage form: Powder identical in appearance, texture, and packaging to the active product
  • Dosage: One sachet per administration
  • Frequency: Twice daily
  • Route of administration: Oral
  • Duration: 12 weeks
  • Distinguishing characteristics:
  • Contains no active probiotic strains
  • Formulated to match the organoleptic properties of Ecologic® Barrier to maintain blinding
Outros nomes:
  • Formulação de placebo

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Hemoglobin A1C
Prazo: From enrollment to the end of treatment at 12 weeks
Average blood glucose levels during the past 2 or 3 months
From enrollment to the end of treatment at 12 weeks

Colaboradores e Investigadores

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

Patrocinador

University Medical Center Groningen

Colaboradores

Parnassia Groep
The Dutch Brain Foundation (funding)
KienVIP

Investigadores

  • Investigador principal: Iris E.C. Sommer, Prof. Dr., University Medical Center Groningen

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 junho de 2026

Conclusão Primária (Estimado)

1 de maio de 2029

Conclusão do estudo (Estimado)

1 de maio de 2029

Datas de inscrição no estudo

Enviado pela primeira vez

18 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de maio de 2026

Primeira postagem (Real)

26 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

26 de maio de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

18 de maio de 2026

Última verificação

1 de maio de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • NL88832.042.25

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

INDECISO

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 .

Ensaios clínicos em Probiotic Formula

Pesquisar ensaios semelhantes

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

CROs by country

CROs in Finland

Condições

Doenças Raras

Intervenções de drogas

Suplementos Alimentares

Patrocinador / Colaboradores

Localizações

Se inscrever