- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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 di studio
Iscrizione (Anticipato)
Contatti e Sedi
Luoghi di studio
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Hong Kong, Hong Kong
- Reclutamento
- Prince of Wales Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Metodo di campionamento
Popolazione di studio
Patients with a diagnosis of Crohn's disease or ulcerative colitis defined by endoscopy, radiology and histology
Control 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.
Relatives or household members of both patients with IBD or other diseases and controls will be recruited.
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Setup a large scale biobank
Lasso di tempo: 20 anni
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Istituire una biobanca su larga scala per raccogliere dati come dati clinici completi, come informazioni demografiche e cliniche del paziente (ad es.
età, peso, sesso, storia familiare di IBD, storia di appendicectomia, uso di droghe, ecc.)
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20 anni
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Intestinal microbiota of IBD patient
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 20 anni
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I campioni di studio saranno raccolti per identificare specifici patogeni che inducono la risposta immunitaria innata mediante l'analisi dei risultati di laboratorio (ad es.
analisi della coltura del tessuto cellulare della tossina specifica alle cellule ecc.)
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20 anni
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Microbiota-induced molecular mechanisms
Lasso di tempo: 20 anni
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Saranno raccolti campioni di studio per caratterizzare quali meccanismi molecolari indotti dal microbiota eseguendo la metagenomica del microbioma intestinale nelle feci e campioni di biospia
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20 anni
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Disease pathogenesis
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (EFFETTIVO)
Completamento primario (ANTICIPATO)
Completamento dello studio (ANTICIPATO)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (EFFETTIVO)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (EFFETTIVO)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- IBD Biobank Study
Informazioni su farmaci e dispositivi, documenti di studio
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