Inflammatory Bowel DiseaseNCT02383953
SSAT 054: Non Genetic Factors in the Pathogenesis of IBD in Twins
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by St Stephens Aids Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inflammatory Bowel Disease, Crohn's Disease, Ulcerative Colitis
- How many people
- 200 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 200
Who may be able to join
- Monozygotic twins discordant for IBD
- Monozygotic twins concordant for IBD
- Dizygotic twins discordant for IBD
- Dizygotic twins concordant for IBD
- Healthy controls
Who cannot join
- <18 years old
- Antibiotics within past 3 months of sample collection
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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:
- 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.
- Identification by study sites B) Obtaining formal written consent C) Collection of blood, stool and urine.
- 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).
- Keywords
- twins, IBD, UC, CD
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in DNA methylation patterns between twin pairs
Measured: 1 day (1 visit only)
Difference in microbiota composition and metabolomic profiles between IBD phenotypes
Measured: 1 day (1 visit only)
Comparison of microbiota composition and metabolic profiles with DNA methylation patterns
Measured: 1 day (1 visit only)
Difference in T cell phenotypes and antigen presenting cells between twin pairs discordant for IBD
Measured: 1 day (1 visit only)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2015 (estimated)
- Study startMay 2015
- Primary completionOct 2017 (estimated)
- Study completionOct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St Stephens Aids Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcus Harbord, MD, Principal investigator, Chelsea and Westminster Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383953
- Sponsor's protocol ID
- SSAT 054
- Status last verified
- Oct 2017
- First submitted
- 7 Jan 2015
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non Genetic Factors in the Pathogenesis of Inflammatory Bowel Disease in Twins
- ClinicalTrials.gov ID
- NCT02383953
- Acronym / sponsor ID
- SSAT 054
- Keywords
- twins, IBD, UC, CD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- St Stephens Aids TrustUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2017 (estimated)
- First posted
- 10 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 description
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:
- 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.
- Identification by study sites B) Obtaining formal written consent C) Collection of blood, stool and urine.
- 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).
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 200
Key inclusion criteria (5 listed)
- Monozygotic twins discordant for IBD
- Monozygotic twins concordant for IBD
- Dizygotic twins discordant for IBD
- Dizygotic twins concordant for IBD
- Healthy controls
Key exclusion criteria (3 listed)
- <18 years old
- Antibiotics within past 3 months of sample collection
- Unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marcus Harbord, MD principal investigator
Chelsea and Westminster Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease and Crohn's Disease, run by St Stephens Aids Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in DNA methylation patterns between twin pairs (time frame: 1 day (1 visit only)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2017.