Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000163707
Ethics application status
Approved
Date submitted
8/02/2013
Date registered
11/02/2013
Date last updated
24/07/2019
Date data sharing statement initially provided
24/07/2019
Date results provided
24/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutritional therapy and gut inflammation in adults with newly diagnosed Crohn's disease
Scientific title
To demonstrate patterns and extent of changes in faecal inflammatory markers consequent to exclusive enteral nutrition.
Secondary ID [1] 281921 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gut inflammation 288318 0
nutrition status 288319 0
remission of disease
 288322 0
quality of life 288323 0
personality - conscientiousness 288324 0
Condition category
Condition code
Oral and Gastrointestinal 288673 288673 0 0
Crohn's disease
Diet and Nutrition 288687 288687 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
8 week treatment with exclusive enteral nutrition (liquid diet) instead of corticosteroid therapy. The liquid diet consists of commercially available a polymeric nutrition formula. It will meet all of the participants calorie and nutrient requirements, no food or fluid other than water is allowed. It is to be taken orally, or via nasogastric tube if not tolerated orally, 6 - 8 times per day based on individual requirements.
Intervention code [1] 286483 0
Treatment: Other
Comparator / control treatment
8 week treatment with corticosteroid therapy as prescribed by the participant's gastroenterologist. The corticosteroid medication will be taken orally as per standard practice.
Control group
Active

Outcomes
Primary outcome [1] 288822 0
Demonstrate patterns and extent of changes in faecal inflammatory markers consequent to exclusive enteral nutrition. Upon receipt stool samples will be stored at -80 degrees. Batched stool samples will be subsequently retrieved from storage and used to measure calprotectin, S100A12 and osteroprotegrin by immunoassay using standard methods.
Timepoint [1] 288822 0
Assess at start of intervention, every 2 weeks during 8 week intervention and then after 3 and 6 months
Secondary outcome [1] 301065 0
Define nutrition status of participant cohort. Nutritional status will be measured by albumin, vitamin D, iron status, IGF-1, BMI, body composition (as measured by bioimpedance analysis and skin fold thickness).
Timepoint [1] 301065 0
Assess at start of intervention, every 2 weeks during 8 week intervention and then after 3 and 6 months
Secondary outcome [2] 301066 0
Document remission rate following exclusive enteral nutrition. Remission of disease will be defined as a Crohn's disease activity index (CDAI) of less than 150 or a drop of more than 100 points. CDAI will be measured at baseline, after 4 weeks and after 8 weeks.
Timepoint [2] 301066 0
After 4 weeks and at end of the 8 week intervention
Secondary outcome [3] 301067 0
Document changes in nutritional markers following exclusive enteral nutrition. Serum albumin and IGF-1, weight, bioimpedance analysis skin fold thickness will be measured as markers of nutritional status.
Timepoint [3] 301067 0
Assess at start of intervention, every 2 weeks during 8 week intervention and then after 3 and 6 months
Secondary outcome [4] 301068 0
Assess the impact of exclusive enteral nutrition upon quality of life and disability scores. Quality of life will be measured using the IBDQ and disability will be measured using the Disability Index.
Timepoint [4] 301068 0
Assess at start of intervention, every 2 weeks during 8 week intervention and then after 3 and 6 months

Eligibility
Key inclusion criteria
newly diagnosed ileal or ileo-colonic Crohn's disease
aged 16 - 40 years
willing to take part
able to attend multiple appointments
Minimum age
16 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
active pyschological disorder
possibly requires abdominal surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All patients who meet study inclusion criteria will be informed about study and given the opportunity to take part. Patients who do not want to use exclusive enteral nutrition for whatever reason will be encouraged to use standard therapy of corticosteroids but take part in the study as a convenience control group
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2013
Actual
1/05/2013
Date of last participant enrolment
Anticipated
Actual
4/12/2015
Date of last data collection
Anticipated
Actual
9/06/2016
Sample size
Target
40
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 4857 0
New Zealand
State/province [1] 4857 0
Canterbury

Funding & Sponsors
Funding source category [1] 286708 0
University
Name [1] 286708 0
University of Otago
Country [1] 286708 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
2 Riccarton Avenue
PO Box 4345
Christchurch 8014
Country
New Zealand
Secondary sponsor category [1] 285480 0
Other
Name [1] 285480 0
New Zealand Society of Gastroenterology
Address [1] 285480 0
NZSG Secretariat
5th Floor, RACP College Office
99 The Terrace
PO Box 10-601
Wellington 6143
Country [1] 285480 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288776 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 288776 0
Ethics committee country [1] 288776 0
New Zealand
Date submitted for ethics approval [1] 288776 0
24/01/2013
Approval date [1] 288776 0
02/04/2013
Ethics approval number [1] 288776 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37718 0
Mrs Catherine Wall
Address 37718 0
University of Otago, Christchurch
Department of Paediatrics
2 Riccarton Avenue
PO Box 4345
Christchurch 8014
Country 37718 0
New Zealand
Phone 37718 0
0064 21 2177233
Fax 37718 0
Email 37718 0
[email protected]
Contact person for public queries
Name 37719 0
Catherine Wall
Address 37719 0
University of Otago, Christchurch
Department of Paediatrics
2 Riccarton Avenue
PO Box 4345
Christchurch 8014
Country 37719 0
New Zealand
Phone 37719 0
0064 21 2177233
Fax 37719 0
Email 37719 0
[email protected]
Contact person for scientific queries
Name 37720 0
Catherine Wall
Address 37720 0
University of Otago, Christchurch
Department of Paediatrics
2 Riccarton Avenue
PO Box 4345
Christchurch 8014
Country 37720 0
New Zealand
Phone 37720 0
0064 21 2177233
Fax 37720 0
Email 37720 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Not part of ethics application


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.