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

NCT ID: NCT01823042

Last Updated: 2013-04-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2013-07-31

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.

Conditions

Crohn's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

enteral nutrition+azathioprine

Patients is fasting and receive enteral nutrition and azathioprine treatment.

Group Type: EXPERIMENTAL

azathioprine+enteral nutrition

Intervention Type: DRUG

azathioprine

Patients have regular diet and receive only azathioprine treatment.

Group Type: EXPERIMENTAL

Azathioprine

Intervention Type: DRUG

Interventions

azathioprine+enteral nutrition

Intervention Type: DRUG

Azathioprine

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Zhu Weiming

vice director of General surgery institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

General Surgery Institute,Jinling Hospital

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Facility Contacts

wei ming zhu, PhD,MD

Role: primary

dr_zhuweiming@126.com

+86-25-80860137

Other Identifiers

CDS-2

Identifier Type: -

Identifier Source: org_study_id