Immunological profiles in Inflammatory Bowel Disease

Recruiting

• Conditions: IBD; Inflammatory Bowel Disease; 10017969; 10003816

• Registration Number: NL-OMON44555
• Lead Sponsor: Rijnstate Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

- 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 Criteria

- 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.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The description of the different mucosal T-cell and serological biomarker<br /><br>immunological profiles at baseline and follow up in newly diagnosed IBD<br /><br>patients </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The correlation between these different immunologic profiles and clinical<br /><br>indicators of disease activity, disease course and response to the received<br /><br>therapy.<br /><br><br /><br>To assess clinical disease activity in case of Crohn*s disease (CD) the<br /><br>Harvey-Bradshaw severity Index and in case of Ulcerative Colitis (UC) the<br /><br>simple clinical activity index will be used.<br /><br>To assess endoscopic activity in case of CD the simple endoscopic score Crohn*s<br /><br>disease (SES-CD) and in case of UC the MAYO score will be used. </p><br>