Immunological Profiles in Inflammatory Bowel Disease

NCT03366090 | Unknown DMC

• 1 other identifier: NL62103.091.17
• Study Type: observational
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, based on interactions between genetic and environmental factors, gut microbiota and the immune system, leading to intestinal inflammation. As the immune reaction itself causes the intestinal damage, differences in components of this immune mediated inflammatory reaction between IBD patients might explain the heterogeneity in response to different therapy strategies. Identifying immune components that are associated to disease activity and prognosis would enable a more personalized treatment.

Conditions

IBD; Immunology; Crohn Disease; Ulcerative Colitis; T Cell Subsets; Immunological Profiles

Outcome Measures

Primary Outcomes (1)

• The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients

  The description of the different immunological profiles at baseline and follow up in newly diagnosed IBD patients

  10-2017 till 6-2020

Secondary Outcomes (1)

• The correlation between these different immunologic profiles and clinical indicators of disease activity, disease course and response to the received therapy.

  10-2017 till 6-2020

Study Arms (2)

IBD patients

Biopsies for immunological analyses

Procedure: Biopsies during coloscopy

healthy controls

Biopsies for immunological analyses

Procedure: Biopsies during coloscopy

Interventions

Biopsies during coloscopy PROCEDURE

During standard ileocolonoscopy intestinal biopsy specimens of the macroscopically most inflamed ileal and colonic mucosa will be obtained at the moment of presentation and during follow up.

IBD patients; healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

The study population will include newly diagnosed adults with IBD and the same patients under treatment during follow up.

You may qualify if:

• A patient who meets the following criteria will be included in this study:
• Patients with clinical symptoms of chronic diarrhoea, rectal blood loss, abdominal pain or weight loss who underwent ileocolonoscopy. Macroscopic findings during ileocolonoscopy must suggest IBD, such as erythema, mucosal friability, oedema an bleeding, erosions, superficial or deep ulcerations and luminal narrowing.
• Ultimately, the diagnosis of IBD must be based on a combination of clinical, endoscopic, histologic and radiologic internationally accepted criteria.
• Patients must be able and willing to provide written informed consent.
• Patients above the age of 18, both men and women. AND/OR
• Known IBD patients under treatment during follow up.

You may not qualify if:

• A patient who meets any of the following criteria will be excluded from participation in this study:
• Patients diagnosed with an immune suppressive disease.
• Patients who underwent splenectomy in the past.
• Patients diagnosed with any other autoimmune diseases (e.g. Diabetes Mellitus type I, rheumatoid arthritis, celiac disease, psoriasis, systemic lupus erythematosus).
• Patients diagnosed with cancer including hematologic malignancies (e.g. (non-)Hodgkin lymphoma , leukemia), solid tumors and carcinoma in situ, within 5 years before screening with the following caveats:
• Follow up IBD-patients who underwent a total colectomy in the past.

Sponsors & Collaborators

• Rijnstate Hospital: lead

Study Sites (1)

Rijnstate

Arnhem, Gelderland, Netherlands

RECRUITING

MeSH Terms

Conditions

Crohn Disease; Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Colitis; Colonic Diseases

Central Study Contacts

B Roosenboom, Msc

CONTACT

+31646623097; broosenboom@rijnstate.nl

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: December 8, 2017
• Study Start: October 1, 2017
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: December 8, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)