The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)

Sponsor

Jinling Hospital, China (Other)

Overall Status

Unknown status

CT.gov ID

NCT01823042

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

11.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease	Drug: azathioprine+enteral nutrition Drug: Azathioprine	N/A

Detailed Description

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Randomized, Controlled, Open-label Study to Assess the the Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD).

Study Start Date :

Oct 1, 2012

Anticipated Primary Completion Date :

Jul 1, 2013

Anticipated Study Completion Date :

Jul 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: enteral nutrition+azathioprine Patients is fasting and receive enteral nutrition and azathioprine treatment.	Drug: azathioprine+enteral nutrition
Experimental: azathioprine Patients have regular diet and receive only azathioprine treatment.	Drug: Azathioprine

Arm

Intervention/Treatment

Experimental: enteral nutrition+azathioprine

Patients is fasting and receive enteral nutrition and azathioprine treatment.

Drug: azathioprine+enteral nutrition

Experimental: azathioprine

Patients have regular diet and receive only azathioprine treatment.

Drug: Azathioprine

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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