|
Welcome
|
|
23 May 2012
|
|
|
| home | my details | ISRCTN Register | mRCT | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| 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 |
| ISRCTN | ISRCTN82416132 |
| ClinicalTrials.gov identifier | |
| Public title | 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 |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N0206135454 |
| Study hypothesis | Is the percentage of patients who will take the trial (polymeric) feed orally significantly greater than the percentage who will take the standard (elemental) feed orally, during a six week (42 day) treatment period? |
| Lay summary | |
| Ethics approval |
Added February 2008:
Liverpool Local Research Ethics Committee granted 9th Feb 2004. Permission to continue a two year retrospective follow up granted 17th August 2006 extending the end date to April 2008. REC ref. 03/12/224/C |
| Study design | Randomised controlled, single blind study |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Digestive System: Crohn's disease |
| Participants - 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. |
| Participants - exclusion criteria |
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 |
| Anticipated start date | 01/03/2004 |
| Anticipated end date | 30/04/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet. |
| Target number of participants | 40 |
| Interventions | Polymeric feed vs standard elemental feed |
| Primary outcome measure(s) | 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 measure(s) |
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. |
| Sources of funding | Royal Liverpool Children's NHS Trust (UK) |
| Trial website | |
| Publications | Abstract presented as oral presentation at BSPGHAN Winter Meeting Jan 23rd-25th 2008 (http://www.bspghan.org.uk/meetings.shtml#winter). |
| Contact name | Mrs Joanne Grogan |
| Address |
RLC NHS Trust
Alder Hey Eaton Road |
| City/town | Liverpool |
| Zip/Postcode | L12 2AP |
| Country | United Kingdom |
| Tel | +44 (0)151 252 5231 |
| Jo.Grogan@rlch-tr.nwest.nhs.uk | |
| Sponsor | Record Provided by the NHSTCT Register - 2004 Update - Department of Health (UK) |
| Address |
The Department of Health,
Richmond House, 79 Whitehall |
| City/town | London |
| Zip/Postcode | SW1A 2NL |
| Country | United Kingdom |
| Tel | +44 (0)20 7307 2622 |
| dhmail@doh.gsi.org.uk | |
| Sponsor website: | http://www.dh.gov.uk/Home/fs/en |
| Date applied | 30/09/2004 |
| Last edited | 22/02/2008 |
| Date ISRCTN assigned | 30/09/2004 |
|
|
|
|
|
| © 2012 ISRCTN unless otherwise stated. | |
|
|
|
|