The Role of shLAIR-1 and hLAIR-2 in IBD

Crohn*s disease (CD) and ulcerative colitis (CD) represent the two main types
of inflammatory bowel disease (IBD), which seems to result from an interaction
among susceptibility genes, environmental triggers, luminal microbial antigens
and the immune system. The immune responses are controlled by the opposing
action of activating and inhibitory signals. Loss of these inhibitory
signalling is often associated with inflammatory or autoimmune disorders. These
inhibitory signals can be provided by inhibitory immune receptors. Human
leukocyte-associated Ig-like receptor (hLAIR-1) is a collagen receptor that
inhibits immune cell function upon collagen binding. The hLAIR-1/collagen
interaction can be regulated by hLAIR-2 and soluble hLAIR-1 (shLAIR-1) by
competing for the same ligand. hLAIR-2 and shLAIR-1 seems to be associated with
a higher inflammatory state. In this study we want to determine whether urinary
concentrations of hLAIR-2 and shLAIR-1 are associated with disease activity in
patients with IBD.

To determine the association between shLAIR-1/ hLAIR-2 levels in urine samples
and clinical and endoscopic disease activity in patients with UC and CD

Patients with Crohn's Disease or ulcerative colitis with an indication for
ileocolonoscopy are informed about this study by their own gastroenterologist
and they will receive information about the study. Within 10 days the
investigator will contact the patients to give additional information and
answer questions. Patients will fill out the informed consent and will sent the
form back to the hospital.

Before the colonoscopy 10 ml blood will be withdrawn from the patient.
Endoscopic disease activity will be assessed using Crohn*s disease Endoscopic
Index of Severity (CDEIS) or using the Mayo Scoring System for Assessment of
Ulcerative Colitis Activity.

All patients will fill out a general questionnaire on demographic data.
Furthermore patients with CD will receive a diary card, and patients with UC
will receive a questionnaire to calculate disease activity. After patients have
completed the questionnaires they will send the questionnaires back to the
hospital. Furthermore patients will collect a urine sample.

Patients will be scheduled for follow up visits at the outpatient clinic at 3,
6, 9 and 12 months. These visits will coincide with the regular visits by their
treating physicians. Before each visit patients with Crohn's Disease will fill
out the diary card, and patients with ulcerative colitis will fill out the
questionnaire to calculate disease activity. Again a urine sample will be
collected.

Patients are asked to fill out 2 questionnaires which takes about 20 minutes
and to collect urine at 3, 6, 9 and 12 months of follow up.