Crohn's Disease
Conditions
Keywords
Crohn's Disease, maintain remission, postoperative recurrence, surgery, living quality
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 maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months\ 6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
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 maintain remission medications,as azathioprine,6-MP, ciclosporin,tripterygium glycosides, had a onset time.The therapeutic effect may appear 3 months\ 6months after taken medicine.There is a treatment blank period between surgery and onset time of maintain remission medications.Enteral nutrition has been used in the induction remission and maintain remission for CD.May be it can fill the treatment blank period.
Interventions
DRUGazathioprine+enteral nutrition
DRUGAzathioprine
Sponsors
Jinling Hospital, China
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change of patients'CDAI. | at 0 week, the 4 weeks, the 8 weeks, the 12weeks |
| patients' endoscopic score(Rutgeerts score). | at the 12weeks |
Secondary
| Measure | Time frame |
|---|---|
| The change of haematological inflammation marker(CRP,ESR) | at 0 week, the 4 weeks, the 8 weeks, the 12weeks |
| The change of patients'IBDQ. | at 2 week, the 6 weeks, the 12 weeks |
| The change of blood routine examination and blood biochemistry. | at 0 week,4 weeks,8 weeks,12 weeks |
Countries
China
Outcome results
None listed