Condition category
Digestive System
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
22/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Joanne Grogan

ORCID ID

Contact details

RLC NHS Trust
Alder Hey
Eaton Road
Liverpool
L12 2AP
United Kingdom
+44 (0)151 252 5231
Jo.Grogan@rlch-tr.nwest.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0206135454

Study information

Scientific title

Acronym

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?

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

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

Digestive System: Crohn's disease

Intervention

Polymeric feed vs standard elemental feed

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/03/2004

Overall trial end date

30/04/2008

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

40

Participant 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

Recruitment start date

01/03/2004

Recruitment end date

30/04/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

RLC NHS Trust
Liverpool
L12 2AP
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Royal Liverpool Children's NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Abstract presented as oral presentation at BSPGHAN Winter Meeting Jan 23rd-25th 2008 (http://www.bspghan.org.uk/meetings.shtml#winter).

Publication citations

Additional files

Editorial Notes