IL-22BP MICI: Study of the Role of Soluble Inhibitor of Interleukin 22, Interleukin 22 Binding Protein (IL-22BP), in Chronic Inflammatory Bowel Disease

• Sponsor: Nantes University Hospital (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02847052
• Collaborator: (none)
• Enrollment: 52
• Actual Duration (Months): 91.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease	Other: Non interventional study

Study Design

• Study Type: Observational
• Actual Enrollment: 52 participants
• Observational Model: Other
• Time Perspective: Retrospective
• Actual Study Start Date: Aug 1, 2014
• Actual Primary Completion Date: Mar 16, 2022
• Actual Study Completion Date: Mar 16, 2022

Outcome Measures

Primary Outcome Measures

1. Regulation of Interleukine 22 binding protein expression in Crohn's disease or Ulcerative colitis [1 day]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria

1. Crohn's disease or Ulcerative colitis

2. Healthy controls paired for age and sex

3. Samples availability in the biobank

4. Signed consent

5. No (Immune Mediated Inflammatory Disorders other than Inflammatory bowel disease

6. No other conditions predicted or known to affect IL-22/IL-22 recepteur /IL-22 binding protein regulation

7. Availability of clinical data

8. Age >18 y.o.

9. No pregnancy

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Nantes University Hospital

Investigators

• Principal Investigator: Jérome Martin, Nantes University Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nantes University Hospital
• ClinicalTrials.gov Identifier: NCT02847052
• Other Study ID Numbers: RC14_0042
• First Posted: Jul 27, 2016
• Last Update Posted: Mar 17, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases

Study Results

No Results Posted as of Mar 17, 2022