Crohn's disease
Conditions
Interventions
UST treatment group (Control group):Ustekinumab
EEN+UST group (Experimental group):Ustekinumab combined with enteral nutrition therapy
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.= 18 years old; 2.The patients were diagnosed as moderate to severe active Crohn's disease (CD) by clinical symptoms, signs, imaging, endoscopy and / or histology within 3 months before enrollment, with small intestine and / or colon stenosis; 3.Active CD is defined as baseline Crohn's disease activity index (CDAI) score = 220 or simple endoscopic score for Crohn's disease (SES-CD) = 4 4.According to Montreal classification, stenosis is defined as "clinical symptoms / signs of persistent lumen stenosis with pre stenosis dilatation or stenosis", specifically defined as: ? The clinical manifestation of stenosis was defined as the occurrence of obstructive symptoms in the past eight weeks, and only (I) Mild to moderate pain (postprandial abdominal pain or increased diet, improved abdominal bowel sounds), no nausea, vomiting and abdominal colic; (II) no abdominal pain, restricted diet; Symptoms consistent with chronic or subacute intestinal obstruction (postprandial abdominal pain in the case of confirmed stenosis), and ? evidence of active intestinal inflammation. ? The definition of stenosis was as follows: compared with the unaffected intestine, cte/mre lumen stenosis decreased by >50%, intestinal wall thickness increased by >25%, and before stenosis 5.The patient has previous failure of traditional treatment (i.e. hormone dependence or hormone resistance) and/or secondary failure (insufficient response or loss of response) or intolerance of anti-TNF agents (including infliximab and adalimumab) (unable to continue treatment due to adverse reactions such as severe infusion reaction, allergy, psoriasis, drug-induced lupus like reaction, demyelinating disease, infection, congestive heart failure, etc.); 6.NRS 2002 score=3. 7. Sign the informed consent form (ICF).
Exclusion criteria
Exclusion criteria: 1. patients with contraindications or intolerance of Ustekinumab; 2. ulcerative colitis, intestinal tuberculosis, and other chronic intestinal infectious diseases; 3. severe intestinal stenosis, perforation, explosive enteritis or intra-abdominal abscess may require surgery during the study; 4. Presence of serious infection, malignant tumor, pregnancy or lactation; 5. Patients with hormone dosage>20mg, or CD treatment changes in the first two months; 6. The tested drugs have been used in the past 60 days; 7. Ileostomy already exists; 8. Other investigators evaluated patients who were not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response of stenosis remissiom; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mucosal healing rate at week 24 and week 56;Success rate of treatment at the 56th week;Response rate of stenosis maintenance at week 56; | — |
Countries
China
Contacts
Public ContactXiaolei Wang
Shanghai Tenth People's Hospital
Outcome results
None listed