Status:
UNKNOWN
Immunological Profiles in Inflammatory Bowel Disease
Lead Sponsor:
Rijnstate Hospital
Conditions:
IBD
Immunology
Eligibility:
All Genders
18+ years
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 inte...
Detailed Description
Rationale: Inflammatory Bowel Diseases (IBD) is a heterogeneous group of diseases regarding clinical presentation, disease course and treatment response. Pathogenesis is complex and multifactorial, ba...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- A patient who meets any of the following criteria will be excluded from participation in this study:
- Possible new IBD patients who use immunosuppressive medication 4 weeks prior to inclusion (e.g. corticosteroids and anti-TNF therapy) either for IBD, other autoimmune diseases or after organ transplantation.
- 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:
- Local basal or squamous cell carcinoma of the skin that has been excised and is considered cured is not exclusionary.
- Chronic myelogenous leukemia, hairy cell leukemia, melanoma, renal cell carcinoma, or Kaposi sarcoma are exclusionary irrespective of the duration of time before screening.
- Cervical smear indicating the presence of adenocarcinoma I situ (AIS), high-grade squamous intraepithelial lesions (HSIL), or cervical intraepithelial neoplasia (CIN) of grade\>1, is exclusionary, irrespective of the duration of time before screening.
- Follow up IBD-patients who underwent a total colectomy in the past.
Key Trial Info
Start Date :
October 1 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 1 2020
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03366090
Start Date
October 1 2017
End Date
July 1 2020
Last Update
December 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Rijnstate
Arnhem, Gelderland, Netherlands