Small Bowel Crohn's Disease Clinical Trial
Official title:
Assessment of Capsule Endoscopy Scoring Index, Clinical Disease Activity and Biological Markers in Small Bowel Crohn's Disease
Background: Small bowel Crohn's disease (SBCD) is a chronic relapsing disease, and clinical
presentation can vary considerably. Patients are frequently assessed by capsule endoscopy
(CE), which enables direct visualization of small bowel mucosal abnormalities; however, the
correlations between CE scoring index (CESI), biological markers, and disease activity
indices remain undefined.
Methods: A prospective study was conducted between October 2008 and February 2011 on 58
established SBCD patients and suspected patients who received a definitive SBCD diagnosis
during study. Patients underwent complete CE, and were scored according to the CESI
(inactive, <135; mild inflammation, 135-790; moderate-severe inflammation, >790) and
Harvey-Bradshaw index (HBI). Statistical correlation between CESI, HBI, C-reactive protein
(CRP), serum albumin, and hemoglobin was assessed. At follow-up (~9 months), 11 of the
patients underwent CE with scoring for CESI, HBI, and CRP.
Parameters CESI To calculate the CESI, the small bowel was divided into three tertiles. The
degree of disease involvement in each tertile was determined by assessing three parameters:
villous edema, ulceration, and stenosis. Endoscopic remission was defined as CESI of <135.
Mild inflammation was defined as CESI of 135-790, and moderate-severe inflammation as ≥790.
HBI HBI was used to assess the clinical disease activity. Patients with HBI >4 were
considered to have clinically active disease.[7]
Blood analysis At the time of CE, patients provided a blood sample for measurement of
hemoglobin, serum CRP, and albumin. Hemoglobin (normal ranges: women, 120-160 g/L and men,
140-180 g/L), albumin (normal range: 35-55 g/L), and CRP (upper limit of normal: <8 mg/L)
were determined by routine laboratory tests.
;
Time Perspective: Prospective
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03646708 -
Response Assessment in SB CD
|
||
| Completed |
NCT03046056 -
Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
|
Phase 2 |