NCT02383953

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 7, 2015

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 10, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

October 26, 2017

Status Verified

October 1, 2017

Enrollment Period

2.4 years

First QC Date

January 7, 2015

Last Update Submit

October 25, 2017

Conditions

Inflammatory Bowel DiseaseCrohn's DiseaseUlcerative Colitis

Keywords

twinsIBDUCCD

Outcome Measures

Primary Outcomes (4)

  • Difference in DNA methylation patterns between twin pairs

    1 day (1 visit only)

  • Difference in microbiota composition and metabolomic profiles between IBD phenotypes

    1 day (1 visit only)

  • Comparison of microbiota composition and metabolic profiles with DNA methylation patterns

    1 day (1 visit only)

  • Difference in T cell phenotypes and antigen presenting cells between twin pairs discordant for IBD

    1 day (1 visit only)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

200

You may qualify if:

  • Monozygotic twins discordant for IBD
  • Monozygotic twins concordant for IBD
  • Dizygotic twins discordant for IBD
  • Dizygotic twins concordant for IBD
  • Healthy controls

You may not qualify if:

  • \<18 years old
  • Antibiotics within past 3 months of sample collection
  • Unable to give informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chelsea and Westminster Hosptial

London, SWIO 9NH, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood (plasma), stool, urine

MeSH Terms

Conditions

Inflammatory Bowel DiseasesCrohn DiseaseColitis, Ulcerative

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesColitisColonic Diseases

Study Officials

  • Marcus Harbord, MD

    Chelsea and Westminster Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 7, 2015

First Posted

March 10, 2015

Study Start

May 1, 2015

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 26, 2017

Record last verified: 2017-10

Locations

GB(1)