Ulcerative Colitis Clinical Trial
Official title:
Non Genetic Factors in the Pathogenesis of Inflammatory Bowel Disease in Twins
This study aims to investigate the role of non-genetic factors in the pathogenesis of inflammatory bowel disease.An exploratory study to investigate differences between the epigenome, microbiota and functional immunology in twins discordant for inflammatory bowel disease.
Background: The inflammatory bowel diseases (IBD), Crohn's Disease (CD) and Ulcerative
Colitis (UC), are debilitating conditions with a complex aetiology. The biggest risk factor
for developing IBD is having an affected first degree relative. However when an identical
twin is diagnosed with IBD, the other twin goes on to develop the condition in only 20-55% of
cases.
Recent research suggests the microbiota the ecosystem of bacteria within the gut may trigger
disease in susceptible individuals. Another important research area is the epigenome changes
to the structure and regulation of our genome which occur throughout our life. It is known
that siblings of Crohn's Disease sufferers have a changes to the immune system characteristic
of Crohn';s. However it is not known whether these changes are due to genetic similarity or
shared environment. Comparison between mono and dizygotic twins elucidates the relative
importance of genetic and environmental factors.
Primary Objective: An exploratory study to investigate differences between the epigenome,
microbiota and functional immunology in twins discordant for inflammatory bowel disease.
Study Design: Multicentre basic science study involving human participants
Planned sample size: 200 data subjects (100 twin pairs)
Methodology:
A) Identification of twin pairs where one or both have inflammatory bowel disease via:
1. IBD Nixon Twin and Multiplex Registry.
2. Advertising for twin pairs via BSG website and newsletters/patient support groups/social
media sites/clinic posters.
3. Identification by study sites B) Obtaining formal written consent C) Collection of
blood, stool and urine.
D) The following analysis will be carried out:
- Epigenetics (blood) DNA extraction and subsequent methylation analysis and bisulphate
conversion with 450 Illumina beadchip assay
- Functional immunology (blood) - flow cytometry of CD3, CD4 and CD8 cells. (London Twin
pairs discordant for Crohn's Disease)
- 16S rRNA gene sequencing (stool) - of bacterial DNA
- Metabolomic profiling (Urine and stool) - using Nuclear Magnetic Resonance (NMR) and
mass spectrometry E) Collection of dietary history information for the previous 72hr
period Study Duration: 2 years (single visit).
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