NCT02847052

Brief Summary

IL-22 is an IL-10 family cytokine that plays major actions to increase intestinal epithelial barrier function and regeneration during experimental colitis. IL-22 binding protein is a small, soluble, and secreted protein potently inhibiting IL-22 actions through preventing the binding with IL-22 Recepteur. This study aims at characterizing how IL-22 binding protein is regulated in Inflammatory bowel disease to better understand the way IL-22 acts on epithelial cells during flares of the disease.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2014

Longer than P75 for all trials

Status
terminated

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

Study Start

First participant enrolled

August 1, 2014

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

July 25, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 16, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 16, 2022

Completed
Last Updated

March 17, 2022

Status Verified

March 1, 2022

Enrollment Period

7.6 years

First QC Date

July 25, 2016

Last Update Submit

March 16, 2022

Conditions

Inflammatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

  • Regulation of Interleukine 22 binding protein expression in Crohn's disease or Ulcerative colitis

    1 day

Interventions

Non interventional studyOTHER

Eligibility Criteria

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

Inflammatory bowel disease, Retrospective, controlled, open, monocentric study

You may qualify if:

  • Crohn's disease or Ulcerative colitis
  • Healthy controls paired for age and sex
  • Samples availability in the biobank
  • Signed consent
  • No (Immune Mediated Inflammatory Disorders other than Inflammatory bowel disease
  • No other conditions predicted or known to affect IL-22/IL-22 recepteur /IL-22 binding protein regulation
  • Availability of clinical data
  • Age \>18 y.o.
  • No pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Jérome Martin

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 25, 2016

First Posted

July 27, 2016

Study Start

August 1, 2014

Primary Completion

March 16, 2022

Study Completion

March 16, 2022

Last Updated

March 17, 2022

Record last verified: 2022-03