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
DOI	https://doi.org/10.1186/ISRCTN82416132
Protocol serial number	N0206135454
Sponsor	Department of Health
Funder	Royal Liverpool Children's NHS Trust (UK)

Submission date: 30/09/2004
Registration date: 30/09/2004
Last edited: 31/05/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Joanne Grogan
Scientific

RLC NHS Trust
Alder Hey
Eaton Road
Liverpool
L12 2AP
United Kingdom

Phone	+44 (0)151 252 5231
Email	Jo.Grogan@rlch-tr.nwest.nhs.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled, single blind study
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific 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
Study objectives	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?
Ethics approval(s)	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
Health condition(s) or problem(s) studied	Digestive System: Crohn's disease
Intervention	Polymeric feed vs standard elemental feed
Intervention type	Other
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.
Key secondary outcome measure(s)	Added February 2008: 1. Paediatric Crohns Disease Activity Index (PCDAI): The primary outcome measure of this study is the evaluation of these enteral diets to induce remission in acute Crohns 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 Crohns disease activity.
Completion date	30/04/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Upper age limit	16 Years
Sex	All
Target sample size at registration	40
Total final enrolment	34
Key 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.
Key exclusion criteria	Added February 2008: 1. Under 5 years 2. History of Crohns disease or colitis 3. Current use of steroids or other anti-inflammatory medication 4. Colonic Crohns 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 Crohns disease) that would interfere with subjects compliance to the protocol requirements or with the Investigators interpretation of the study findings 10. Evidence of enteric pathogens or toxin i.e. Clostridium difficile 11. Previous enrolment in the study protocol
Date of first enrolment	01/03/2004
Date of final enrolment	30/04/2008

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

RLC NHS Trust

Liverpool
L12 2AP
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2012	31/05/2019	Yes	No
Abstract results				No	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

31/05/2019: Publication reference and total final enrolment added.