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- Ensaio Clínico NCT03855657
Biobank - Investigating the Gut Microbiota, Genetics, Epigenetics and Metabolites
Investigating the Intestinal Microbiota, Epigenetic Markers and Body Fluid Metabolites to Identify Biomarkers for Inflammatory Bowel Diseases
Visão geral do estudo
Status
Condições
Descrição detalhada
Inflammatory bowel disease (IBD) affects 1 in 500 to 1,000 people in the West. Previously a disease predominantly of the West, there is now a marked increase in the incidence of ulcerative colitis (UC) and Crohn's disease (CD) in Asia, with an estimated prevalence of 1 in 3,000 and 1 in 10,000 respectively [1]. IBD is thought to result from an aberrant immune response to intestinal bacteria in genetically susceptible individuals [2]. Genetic variants have been shown to contribute to an increased IBD risk. Although genetic traits predispose to the development of IBD in Asia, the change in epidemiology that has occurred over only a few decades suggests that other, presumably environmental factors play the major role in the development of disease [10].
IBD patients often rely on medical therapy to achieve remission. Due to the diverse features of severity, phenotypes, clinical courses and responses, personalizing IBD therapy is important to maximize management efficacy, minimize adverse events and decrease cost. Thiopurines is a key component of medications in the treatment of Inflammatory Bowel Disease (IBD). However, achieving an optimal efficacious thiopurine dosing can be difficult, as up to 10% of patients have dose-dependent toxicities and up to 9% of patients are resistant to thiopurine therapy [16, 17]. Such clinical toxicity could be due to inherited genetic variation of certain enzyme, leading to an unusual metabolic pathway, which generates toxic metabolites. On the other hand, few studies have studied the longitudinal changes in the gut microbiome with drug treatment in IBD. Shaw et al. characterized 19 children with CD and 4 with ulcerative colitis (UC), showing that dysbiosis at baseline correlated with the degree of inflammatory burden of luminal disease.Therefore, identification of comprehensive targets for drug monitoring will improve our understanding of the basis for inter-patient variability in drug toxicity and efficacy, and enable more individualized therapy.
Metabolism has an essential role in biological systems; and metabolites represent the end products of this important process from a cell of a certain physiological status. Blood and urine are integrative fluids that incorporates the metabolic outputs at different of the body, and thus providing a metabolic footprint as an end product [4].
Metagenomics which is a study of microbes as communities is also an important approach to study microbiota in human.The interplay between microbiota and genetics gives unique transcription profiles in the gut, and gene expression analyses provide insights into the transcriptional activity and functional molecular pathways underlying disease progression. Therefore, deep sequencing analysis of the colon suggests hypotheses about the pathophysiological processes in IBD patients. Further transcriptomics study and in combination with other meta'omics studies will provide the basis for in-depth understanding of IBD pathogenesis.
Due to the bio-clinical complexity of diseases and microbiota, a long term, large-scale prospective biobank is necessary to carry out meaningful research. This biobank will provide a powerful platform for studying a range of complex factors associated with IBD that are of great relevance to public health. Such biobank may be extended to other diseases including GI diseases and autoimmune disorder, which may possibly provide insight to the role of microbiota in human health.
In conclusion, a comprehensive understanding of the intestinal ecosystem, epigenetic, metabolic and transcription profiles, as well as their mechanisms in the disease pathogenesis in patients with IBD and other diseases may help us identify potential biomarkers. However, our current knowledge about them is still very limited, particularly in Asian patients, who have not been extensively researched. Further investigation in this field is needed. To serve these purposes, we aim to setup a large scale biobank with comprehensive clinical data.
Tipo de estudo
Inscrição (Antecipado)
Contactos e Locais
Locais de estudo
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Hong Kong, Hong Kong
- Recrutamento
- Prince of Wales Hospital
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Pacientes com diagnóstico de doença de Crohn ou colite ulcerativa definida por endoscopia, radiologia e histologia
O controle incluirá indivíduos submetidos à colonoscopia para triagem de pólipos ou câncer colorretal, ou investigações de sintomas gastrointestinais, e amigos e cônjuges ou parceiros de pacientes no Prince of Wales Hospital ou Alice Ho Miu Ling Nethersole Hospital, ou quaisquer indivíduos que estejam interessados em participar deste estudar.
Serão recrutados parentes ou membros da família de pacientes com DII ou outras doenças e controles.
Descrição
Inclusion Criteria:
- Patient ≥18 with a diagnosis of Crohn's disease or ulcerative colitis
- Informed Consent obtained
Exclusion Criteria:
- Known current infection with an enteric pathogen
- Previously been diagnosed with IBD (Control)
- Have a first of second degree relative with IBD (Control)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
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Inflammatory Bowel Disease Patient
Patient with confirmed diagnosis of Inflammatory Bowel Disease
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Healthy control
Controls (non-IBD) will comprise individuals undergoing colonoscopy for polyp or colorectal cancer screening, or investigations of gastrointestinal symptoms, and friends and spouses or partners of patients at Prince of Wales Hospital or Alice Ho Miu Ling Nethersole Hospital, or any individuals who are interested to participate in this study.
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Healthy relatives of Inflammatory Bowel Disease patient
Relatives or household members of both patients with IBD or other diseases and controls will be recruited.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Setup a large scale biobank
Prazo: 20 anos
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Configure um biobanco de grande escala para coletar dados, como dados clínicos abrangentes, como informações demográficas e clínicas do paciente (por exemplo,
idade, peso, sexo, histórico familiar de DII, histórico de apendicectomia, uso de drogas, etc.)
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20 anos
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Intestinal microbiota of IBD patient
Prazo: 20 years
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Study samples will be collected to characterize which microbiota affect severity of IBD by performing metagenomics of gut microbiome in stool and biospy samples
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20 years
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Genetics and epigenetic markers in IBD
Prazo: 20 years
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Study samples will be collected from patients with IBD and other diseases for genetic material isolation and gene expression checking by performing PCR.
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20 years
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Therapeutic drug monitoring
Prazo: 20 years
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To understand the metabolic pathway leading to the target metabolites and therapeutic drug monitoring during following up by filling in questionniare
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20 years
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Biomarker of IBD
Prazo: 20 years
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Study samples will be collected to characterize which microbiota affect severity of IBD by performing metagenomics of gut microbiome in stool and biospy samples
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20 years
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Pathobionts of IBD
Prazo: 20 anos
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Amostras do estudo serão coletadas para identificar patobiontes específicos que induzem resposta imune inata por análise de resultado laboratorial (por exemplo,
análise de cultura de tecido celular de toxina específica para células, etc.)
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20 anos
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Microbiota-induced molecular mechanisms
Prazo: 20 anos
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Amostras do estudo serão coletadas para caracterizar quais mecanismos moleculares induzidos pela microbiota, realizando metagenômica do microbioma intestinal em fezes e amostras de biópsia
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20 anos
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Disease pathogenesis
Prazo: 20 years
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Study samples will be collected to characterize which microbiota induces disease by performing metagenomics of gut microbiome in stool and biospy samples
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20 years
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Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (REAL)
Conclusão Primária (ANTECIPADO)
Conclusão do estudo (ANTECIPADO)
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
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- IBD Biobank Study
Informações sobre medicamentos e dispositivos, documentos de estudo
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