A Specific Probiotic in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis (ANEMONE)
A. M in thE MOdulation of Gut Microbiota of patieNts With Mild-to-modErate Ulcerative Colitis: a Pilot,Phase 2A, Single-arm, Interventional Study
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
The concept of probiotics dates back to 1907, when Elie Metchnikoff observed that elderly Bulgarian populations consuming fermented dairy products, such as yogurt rich in lactic acid bacteria (LAB), appeared to have increased longevity. This observation formed the basis for the development of traditional probiotics.
Traditional probiotics are defined as live microorganisms that confer a health benefit when administered in adequate amounts. These microbes are typically derived from fermented foods or the human gastrointestinal tract. Most belong to a limited number of well-characterized genera, particularly Lactobacillus and Bifidobacterium. Certain strains of these bacteria are recognized as safe and have been granted Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA). In addition, they are technologically robust, meaning they can be easily cultivated and mass-produced for industrial applications.
Despite their popularity and widespread use in dietary supplements and functional foods, traditional probiotics are not specifically developed as treatments for diseases. Their mechanisms of action include modulation of gut microbiota, enhancement of the gut barrier, and interaction with the immune system. However, most supporting evidence comes from laboratory (in vitro), animal, or ex vivo studies rather than strong clinical trials. As a result, EFSA has evaluated more than 400 probiotic-related claims but has not approved any specific health claims due to insufficient conclusive evidence.
In recent years, advances in microbiota and microbiome research-particularly through metagenomics and microbial profiling-have significantly expanded our understanding of the gut ecosystem. It is now well established that dysbiosis, or imbalance in gut microbiota composition, is associated with a wide range of diseases, including metabolic, immune, and inflammatory disorders.
These scientific developments have led to the identification of new microorganisms that are associated with healthy individuals rather than traditional dietary sources. These microbes are classified as Next-Generation Probiotics (NGPs) or Live Biotherapeutic Products (LBPs). Unlike traditional probiotics, NGPs are not restricted to classical genera and do not have a long history of safe human use. Instead, they are often identified through comparative studies analyzing differences between healthy and diseased microbiomes.
NGPs represent a promising new frontier in microbiota-based therapies, as they may be specifically selected or engineered to target particular diseases or health conditions. A growing number of potentially beneficial species have been identified, opening new opportunities for precision medicine and personalized interventions based on gut microbiota composition.
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Antonio Gasbarrini
- Número de telefone: 0630157104
- E-mail: antonio.gasbarrini@unicatt.it
Locais de estudo
-
-
RM
-
Roma, RM, Itália, 00146
- Recrutamento
- Fondazione Policlinico Universitario Agostino Gemelli, IRCCS
-
Contato:
- Antonio Gasbarrini
- Número de telefone: 0630157104
- E-mail: antonio.gasbarrini@unicatt.it
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
Inclusion Criteria:
- Men or women 18 to 80 years of age at the time of consent
- Previous diagnosis of ulcerative colitis, based on available endoscopic and histopathologic report, at least 3 months before screening
- Mild-to-moderate disease activity based on Modified Mayo Score that should be between 4 and 6 with an endoscopic subscore >1 based on endoscopic evaluation performed during screening phase
- Subjects are permitted to receive a concomitant therapeutic dose of the following IPs: Corticosteroids (≤20 mg/day of prednisone equivalents) at stable dose for at least 2 weeks before screening and mesalazine or other 5-ASA (including salazopyrin) at stable dose for at least 4 weeks before screening
- Ability to provide a written informed consent and to be compliant with the schedule of protocol assessments.
Exclusion Criteria:
- concomitant immunosuppressive therapy, including but not limited to thiopurines, methotrexate, anti-TNFalfas, anti-integrins and anti-IL12/23 or JAK inhibitors. Biological therapies should be stopped at least 8 weeks before baseline, except for ustekinumab which should be stopped for at least 12 weeks before baseline, small molecules agent should be discontinued 5 elimination half-lives within baseline. Patients that have been previously treated with ≥ 2 advanced/biological drugs (even if belonging to the same class) will be excluded.
- Intolerance to topical therapy (enemas)
- Allergy to A. muciniphila or any other component of the IP
- Crohn's disease or inflammatory bowel disease unclassified (IBD-U)
- Subject who received IV/intramuscular corticosteroids within 14 days prior to Screening or during the Screening period.
- Subject who received topical therapy (i.e., enema or suppository of aminosalicylates / corticosteroids) within 14 days prior to Screening or during the Screening period.
- Subject who received fecal microbial transplantation within 3 months prior to Baseline.
Subjects with the following chronic or active infections:
- Active, chronic, or recurrent infection that based on the Investigator's clinical assessment makes the subject unsuitable candidate for the study
- Infection with C. difficile, intestinal pathogen bacteria, intestinal parasites as identified during Screening as per clinical practice,
- Are infected with human immunodeficiency virus (HIV),
- Subject who has any condition including any physical, psychological, or psychiatric condition, which in the opinion of the Investigator, would compromise the safety of the subject or the quality of the data and renders the subject an unsuitable candidate for the study.
- Pregnancy and breastfeeding
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Type of patients
patients with UC and CD
|
For the collection of a few additional biopsies
rectal administration of a specific probiotic
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Evaluate the effect of rectal administered a specific probiotic in Rectal mucosal healing
Prazo: 1 year
|
The primary aim of this study is to evaluate the effect of rectal administered a specific probiotic on gut microbiota in patients with UC and CD for Rectal Mucosal Healing with mayo score.
Rectal mucosal healing assessed by Mayo Endoscopic Subscore (MES) (range 0-3; lower scores indicate better mucosal healing and lower disease activity).
|
1 year
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
evaluate the feasibility of a specific probiotic
Prazo: 1 year
|
To evaluate the feasibility of a specific probiotic rectal administration in a cohort of patients with mild-to-moderate ulcerative colitis by nursing notes
|
1 year
|
|
Evaluate the tolerability of rectal a specific probiotic in Rectal Mucosal healing
Prazo: 1 year
|
Tolerability of rectally administered probiotic assessed by the incidence of adverse events and treatment discontinuations.
|
1 year
|
|
Evaluate the quality of life
Prazo: 1 year
|
Quality of life assessed by the Inflammatory Bowel Disease Questionnaire (IBDQ) (range 32-224; higher scores indicate better quality of life).
|
1 year
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças Intestinais
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Gastroenterite
- Doenças Inflamatórias Intestinais
- Colite
- Colite ulcerativa
- Doença de Crohn
- Terapêutica
- Rotas de administração de medicamentos
- Terapia medicamentosa
- Administração, mucosa
- Administração, tópica
- Administração, retal
Outros números de identificação do estudo
- 6991
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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 .