Status:
UNKNOWN
The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)
Lead Sponsor:
Jinling Hospital, China
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maint...
Detailed Description
Crohn's disease(CD) is a agnogenic disease which has a lifelong relapse tendency even after surgery treatment.So maintain remission medications were routinely given to patients after surgery.But maint...
Eligibility Criteria
Inclusion
- Subjects should have a definitive diagnosis of Crohn's disease, based on WHO criteria
- Subjects having curative resection/ileocolonic anastomosis，pathologically diagnosed as Crohn's disease
- Lesions located in ileum or ileocecal region
- Males and females ≥ 18 years old, including women who are not pregnant or lactating at the time of enrollment.
- Body weight between 40 and 100 kg, inclusive.
- Subjects should have a CDAI score \<150 at week 0
- Able to swallow tablets
- Are capable of providing written informed consent and obtained at the time of enrollment
- Willing to adhere to the study visit schedule and other protocol requirements.
Exclusion
- Bacterial,viral or other microbial infection(including HIV)
- any of the following medications taken within 12 weeks before surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or other investigational drugs
- any of ongoing therapy for Crohn's disease with: 5-ASA compounds, steroids, immune modifiers, systemic antibiotics, and tube feeding
- Needing orally administered corticosteroids for the treatment of other diseases. Inhaled or dermatologic preparations are acceptable.
- Previous or current use of infliximab.
- current use of prescription doses or chronic/frequent use of NSAIDs
- Treatment with narcotic pain medications. (Anti-diarrheal agents such as loperamide and diphenoxylate are permitted, providing that the dose is not increased during the study period.)
- History of pancreatitis, except for subjects with a known but removed cause(such as gallstone pancreatitis)
- WBC \<3.0 x 109/L, hemoglobin \<80 g/L, Platelets\<50,000/mm3 at the time of enrollment (or within the previous 6 months, if known)
- History of abnormal liver function tests, including AST or ALT \>1.5 times upper limit of normal, alkaline phosphatase \>2 times upper limit of normal, total bilirubin \>2.5 mg/dL at screening (or within the previous 6 months, if known)
- With short bowel syndrome (defined as requiring oral or parenteral supplemental or total nutrition to maintain stable body weight, or more than 100 cm of small bowel resected)
- History of malignancy
- Women who are pregnant or lactating at the time of enrollment, or who intend to be during the study period.
- Participation in other clinical trial within the past 6 months
Key Trial Info
Start Date :
October 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01823042
Start Date
October 1 2012
End Date
July 1 2013
Last Update
April 4 2013
Active Locations (1)
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1
General Surgery Institute,Jinling Hospital
Nanjing, Jiangsu, China, 210000