Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03855657 |
| Other study ID # |
IBD Biobank Study |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 2014 |
| Est. completion date |
July 2034 |
Study information
| Verified date |
February 2023 |
| Source |
Chinese University of Hong Kong |
| Contact |
Siew Chien Ng, PhD |
| Phone |
852-35053996 |
| Email |
siewchienng[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
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]. The rapid increase of IBD in Asian raising concern
of investigators. Therefore setting up a large scale biobank with comprehensive clinical data
is require.
Description:
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.
