Clinical Trial: SSAT 054: Non Genetic Factors in the Pathogenesis of IBD in Twins
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: Non Genetic Factors in the Pathogenesis of Inflammatory Bowel Disease in Twins
Brief Summary: 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.
Detailed Summary:
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:
- IBD Nixon Twin and Multiplex Registry.
- Advertising for twin pairs via BSG website and newsletters/patient support groups/social media sites/clinic posters.
Sponsor: St Stephens Aids Trust
Current Primary Outcome:
- Difference in DNA methylation patterns between twin pairs [ Time Frame: 1 day (1 visit only) ]
- Difference in microbiota composition and metabolomic profiles between IBD phenotypes [ Time Frame: 1 day (1 visit only) ]
- Comparison of microbiota composition and metabolic profiles with DNA methylation patterns [ Time Frame: 1 day (1 visit only) ]
- Difference in T cell phenotypes and antigen presenting cells between twin pairs discordant for IBD [ Time Frame: 1 day (1 visit only) ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: St Stephens Aids Trust
Dates:
Date Received: January 7, 2015
Date Started: May 2015
Date Completion: January 2017
Last Updated: March 24, 2016
Last Verified: March 2016
