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

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2004
INTERVENTION: Polymeric feed vs standard elemental feed CONDITION: Digestive System: Crohn's disease ; Digestive System ; Crohn's disease PRIMARY OUTCOME: The percentage of patients who took the trial (polymeric) feed orally compared to the percentage that took the standard (elemental) feed orally during a six‐week (42 day) treatment period. SECONDARY OUTCOME: Added February 2008:; ; 1. Paediatric Crohn?s Disease Activity Index (PCDAI): The primary outcome measure of this study is the evaluation of these enteral diets to induce remission in acute Crohn?s disease. Clinical remission is defined as a (PCDAI) <10. PCDAI will be calculated from assessment of the degree of abdominal pain, stool pattern, general well being, presence of extra‐intestinal manifestations, physical examination findings, weight and height, haematocrit, ESR and albumin. PCDAI will be calculated prior to entry in the trial and at 6 weeks to assess the efficacy of the enteral feed. ; 2. Nutritional Status: Weight will be measured before and after the period of enteral feeding. Standard deviation (Z) scores will be calculated, using computer software designed for this purpose, to assess changes in the nutritional status of the participants.; 3. Antioxidant Status: Plasma and red blood cell fatty acid profile measures of antioxidant status (Vitamins A C and E assay and Isoprostanes) see appendix IV of the protocol for background information.; 4. Stool Analysis: Stool specimens will be examined for enteric pathogens, parasites and Clostridium difficile toxin at baseline only to ensure the patient does not have a gastrointestinal infection. Faecal calprotectin (Appendix V of the protocol) will be measured at baseline and at the end of the study in order to assess the degree of neutrophil activation and inflammation within the gut, an indicator of Crohn?s disease activity. INCLUSION CRITERIA: 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.
Epistemonikos ID: db88d8a8e31fbbae52867e4cbbcebf602db9f2a1
First added on: Aug 21, 2024