A comparison of a new formulation feed compared with the standard use of emsogen as primary enteral nutrition therapy to attain remission in paediatric Crohn's Disease

Department of Health0 个研究点目标入组 34 人开始时间: 2004年9月30日最近更新: 2019年6月26日

适应症

试验速览

Abstract presented as oral presentation at BSPGHAN Winter Meeting Jan 23rd-25th 2008 (http://www.bspghan.org.uk/meetings.shtml#winter). 2. 2012 results in: https://www.ncbi.nlm.nih.gov/pubmed/21425210 (added 31/05/2019)

•Paediatric patients (male and female up to 16 years of age) on first presentation of Crohn's disease. 20 patients will be randomised into each group (total n = 40) upon diagnosis.

•Added February 2008:
•1. Under 5 years
•2. History of Crohn?s disease or colitis
•3. Current use of steroids or other anti-inflammatory medication
•4. Colonic Crohn?s disease without involvement of the small bowel
•5. Females who are pregnant or breast-feeding
•6. Severe disease including:
•6.1 Intestinal perforation
•6.2 Significant intestinal obstruction
•6.3 Abdominal abscess
•6.4 Toxic mega colon
•6.5 Severe gastrointestinal hemorrhage
•6.6 Mid-jejunal fistulas which preclude the use of enteral nutrition
•7. Remaining small bowel less than 180 cm (6 feet) with an ileostomy
•8. Need of TPN because of short bowel syndrome
•9. Clinically significant disease (other than defined active Crohn?s disease) that would interfere with subjects compliance to the protocol requirements or with the Investigator?s interpretation of the study findings
•10. Evidence of enteric pathogens or toxin i.e. Clostridium difficile
•11. Previous enrolment in the study protocol

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