Inflammatory bowel disease, IBD
Conditions
Interventions
EEN+ADA group:N/A
PEN+ADA group:N/A
Sponsors
The Second Affiliated Hospital of Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged 18-65 with moderate to severe CD; 2. Obstructive symptoms (postprandial abdominal pain confirming narrow obstruction) consistent with chronic or subacute ileus in the past 8 weeks, unless there is only (1) mild to moderate pain (postprandial abdominal pain or pain exacerbated by diet and improved with abdominal bowel sounds), no nausea, vomiting, or abdominal cramps; (2) no dietary restriction for abdominal pain; 3. By radiography or endoscopy, there is clear evidence of a narrowing of the lumen due to the disease itself, that is, any of the following: (1) MRI or CT of the small intestine: On MRI or CT of the small intestine, there is a stenosis where: 1) the lumen diameter is reduced by > 50% compared to the adjacent proximal intestine; 2) increased intestinal wall thickness by > 25%; 3) there is a narrowing in all scanning acquisition; 4) intestinal wall enhancement (>100); 5) intestinal wall edema or ulceration (based on MRI activity index MaRIA score); 6) prestricture dilatation > 3 cm; (2) Endoscopic examination: stenosis of the intestine whose lumen diameter is less than 12 mm or even cannot be passed through the endoscope.
Exclusion criteria
Exclusion criteria: 1. Patients with CD who currently need emergency surgery or endoscopic intervention (such as patients with acute obvious ileus), or who are judged by clinicians to need surgery within 2 months. 2. Active perianal sepsis, abdominal abscess, intestinal fistula, abdominal adhesion and other perforating symptoms or signs. 3. Intestinal obstruction, abdominal abscess and isolated intestinal stricture caused by operation. 4. Patients with CD who have used ADA in the past 12 months, or who have failed to use ADA in the past, and who have contraindications to ADA or other reasons (such as prior allergy to ADA) cannot tolerate the treatment drugs used in this study. 5. Patients who have enteral nutrition contraindications, are allergic to known enteral nutrition ingredients or have failed to respond to previous EEN for 12 weeks, or cannot successfully tolerate or tolerate CD for jejunal catheterization, nasogastric tube aspiration, intravenous infusion, etc. 6. Contraindications to magnetic resonance enterography (MRE) or CT of the small intestine, such as a positive chest radiograph for tuberculosis or a positive tuberculin skin test, a history of myocardial infarction, heart failure, or malignant disease (other than skin basal cell carcinoma) in the last five years, and demyelinating nervous system diseases. 7. CD patients with intestinal dysplasia (such as a diagnosis of short bowel syndrome), colostomy, or colorectal tumors. 8. Patients with CD complicated with active gastrointestinal bleeding, shock, severe diarrhea, intractable vomiting and severe malabsorption syndrome. 9. Severe liver and kidney dysfunction. 10. Active bacterial or viral infection. 11. Pregnant and nursing patients. 12. Severe hemodynamics, unstable vital signs, or the presence of rapidly progressing or terminal disease, and the expectation of death during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Discontinuation of adalimumab at week 52; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with at least a 3-point reduction in HBI;Proportion of patients with at least a 4-point reduction in HBI;Effectiveness of ADA; | — |
Countries
China
Contacts
Public ContactChen Yan
The Second Affiliated Hospital of Zhejiang University School of Medicine
Outcome results
None listed