- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Förväntat)
Kontakter och platser
Studieorter
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Hong Kong, Hong Kong
- Rekrytering
- Prince of Wales Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Patienter med diagnosen Crohns sjukdom eller ulcerös kolit definierad av endoskopi, radiologi och histologi
Kontrollen kommer att omfatta individer som genomgår koloskopi för screening av polyp eller kolorektal cancer, eller undersökningar av gastrointestinala symtom, och vänner och makar eller partners till patienter på Prince of Wales Hospital eller Alice Ho Miu Ling Nethersole Hospital, eller andra individer som är intresserade av att delta i detta studie.
Släktingar eller hushållsmedlemmar till båda patienter med IBD eller andra sjukdomar och kontroller kommer att rekryteras.
Beskrivning
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)
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Setup a large scale biobank
Tidsram: 20 år
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Skapa en storskalig biobank för att samla in data såsom omfattande klinisk data, såsom patientens demografiska och kliniska information (t.
ålder, vikt, kön, familjehistoria av IBD, blindtarmsoperation, droganvändning etc.)
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20 år
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Intestinal microbiota of IBD patient
Tidsram: 20 years
|
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
Tidsram: 20 years
|
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
Tidsram: 20 years
|
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
Tidsram: 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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Patobionter av IBD
Tidsram: 20 år
|
Studieprover kommer att samlas in för att identifiera specifika patobionter som inducerar medfödda immunsvar genom analys av laboratorieresultat (t.ex.
cellvävnadsodlingsanalys av specifikt toxin till celler etc.)
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20 år
|
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Microbiota-induced molecular mechanisms
Tidsram: 20 år
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Studieprover kommer att samlas in för att karakterisera vilka mikrobiota-inducerade molekylära mekanismer genom att utföra metagenomik av tarmmikrobiom i avförings- och biospionprover
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20 år
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Disease pathogenesis
Tidsram: 20 years
|
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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (FAKTISK)
Primärt slutförande (FÖRVÄNTAT)
Avslutad studie (FÖRVÄNTAT)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (FAKTISK)
Uppdateringar av studier
Senaste uppdatering publicerad (FAKTISK)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- IBD Biobank Study
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