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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01823042
• Date of registration: 25/03/2013
• Prospective Registration: No
• Primary sponsor: Jinling Hospital, China
• Public title: The Efficacy of Enteral Nutrition in Fill of the Treatment Blank Period of the Postoperative Maintain Remission Medication for Crohn's Disease (CD)
• Scientific 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).
• Date of first enrolment: October 2012
• Target sample size: 100
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01823042
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: N/A

Countries of recruitment

China

Contacts

• Name: wei ming zhu, PhD,MD

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Drug: Azathioprine

Drug: azathioprine+enteral nutrition

Primary Outcome(s)

patients' endoscopic score(Rutgeerts score). [Time Frame: at the 12weeks]

The change of patients'CDAI. [Time Frame: at 0 week, the 4 weeks, the 8 weeks, the 12weeks]

Secondary Outcome(s)

The change of haematological inflammation marker(CRP,ESR) [Time Frame: at 0 week, the 4 weeks, the 8 weeks, the 12weeks]

The change of blood routine examination and blood biochemistry. [Time Frame: at 0 week,4 weeks,8 weeks,12 weeks]

The change of patients'IBDQ. [Time Frame: at 2 week, the 6 weeks, the 12 weeks]

Secondary ID(s)

CDS-2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors