Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001032842
Ethics application status
Approved
Date submitted
25/09/2012
Date registered
25/09/2012
Date last updated
20/04/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of liquid special diet to induce gut healing when used as a sole nutrition for newly diagnosed children with Crohn's Disease.
Scientific title
Exclusive enteral nutrition and mucosal healing in newly diagnosed children with Crohn’s disease : Comparison of clinical parameters, biomarkers, microbiome and genotype between responders and non-responders.
Secondary ID [1] 281295 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Crohn's Disease 287505 0
Condition category
Condition code
Oral and Gastrointestinal 287833 287833 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The diagnosis of Crohn’s disease willbe based on established clinical, endoscopic, histological and radiological criteria. Children will be given either Nutrison (1Kcal/ml, Nutricia UK) through Nasogastric tube (NGT) or Resource (Nestle) orally after dietetic consultation for total duration of 8 weeks.Prescribed volume will base on estimated caloric requirement aiming to gradully upgrade target volume in 3 to 5 days. In those electing NG tube, insertion can be performed during General Anaesthetic for the diagnostic endoscopy. Children struggling with oral EEN can be offered different flavours or changes to NG route. Clear fluids, Jelly, boiled lollies were allowed empirically and concurrently to improve palatability. A comprehensive evaluation including clinical, standard laboratory, Colonoscopy (review gut lining) and MRE (bowel wall thickness) will be undertaken at diagnosis and after treatment. Faecal samples, additional blood and small tissue biopsies will be collected on both occasions.Other therapies like steroids and early introduction of Imuran before first relapse may be used due to patient preference or clinician discretion but patients will undergo similar assessments at initial visit and 8 weeks.
Intervention code [1] 285762 0
Treatment: Other
Comparator / control treatment
Not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288051 0
Primary end points of the study are to determine efficacy of EEN for inducing early clinical, biochemical, mucosal and transmural remission at 8 weeks.

Measurement at diagnosis and 8 weeks:

PCDAI= Clinical and Biochemistry including CRP
BMI Z= Growth measurements
Mucosal healing= Endoscopic Scoring ( Colonoscopy)
Transmural Healing = MR Enterography
Timepoint [1] 288051 0
At Diagnosis and 8 weeks.
Primary outcome [2] 288052 0
Relate early endoscopic response to subsequent clinical outcomes, specifically endoscopic confirmed relapse, hospitalisation, need to commence biological agent and surgical resection
Timepoint [2] 288052 0
12 and 24 months.
Secondary outcome [1] 299341 0
After an initial expected enrolment of 20 children interim mechanistic analyses will be done to refine the outlined hypotheses.
Additional 30 patients will be enrolled subsequently to identify the changes in mucosal cytokine T regulatory profiles, faecal and mucosal microbiota, genotypes of EEN responders versus EEN non responders and versus those electing for steroids to better understand mechanism of EEN induced remission , target dietary interventions and develop risk stratification of patients.

24 months

Faecal microbiome : Pyrosequencing for microbiome
Mucosal biopsy for Cytokines, T reg & microbiome: ELISA , Microarray, Immunohistochemistry
Blood T reg profile: Flow cytometry
Timepoint [1] 299341 0
24 months

Eligibility
Key inclusion criteria
New Diagnosis of Paediatric Crohn's disease
Minimum age
0 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria included previous exposure to: steroids, conventional Immunomodulators, biological agents; and inability to tolerate oral or Nasogastric (NG) tube EEN for a minimum of 6 weeks.

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)
None
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
None
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 286055 0
Charities/Societies/Foundations
Name [1] 286055 0
ANZ Trustees
Country [1] 286055 0
Australia
Funding source category [2] 286057 0
University
Name [2] 286057 0
Queensland Childrens Medical Research Institute
Country [2] 286057 0
Australia
Primary sponsor type
Individual
Name
Dr.Zubin Grover
Address
QCMRI
RCH Foundation Building
Herston Road
Herston
4006
QLD
Brisbane
Country
Australia
Secondary sponsor category [1] 284868 0
University
Name [1] 284868 0
Queensland Children Medical Research Institute
Address [1] 284868 0
QCMRI
RCH Foundation Building
Herston Road
Herston 4006
Brisbane
QLD
Country [1] 284868 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288106 0
Queensland Childrens Health Servuce District (RCH) Ethics Committe
Ethics committee address [1] 288106 0
Level 3 Foundation Building
RCH Herston
Herston Road
4006
Brisbane
QLD
Ethics committee country [1] 288106 0
Australia
Date submitted for ethics approval [1] 288106 0
21/11/2009
Approval date [1] 288106 0
08/03/2010
Ethics approval number [1] 288106 0
HREC/09/QRCH/128

Summary
Brief summary
This proposal will confirm short term benefits of EEN on mucosal recovery and, on follow up, the favorable impact on clinical course. It will demonstrate utility or otherwise of phenotypic, genetic, biomarkers and faecal calprotectin to predict response. Mucosal and microbiome characteristics of patients with mucosal recovery will be compared with non responders to better understand mechanisms of efficacy of EEN with expectation of better targeted, safer, better tolerated, non-pharmacological therapies to induce mucosal healing and improve outcomes for children with Crohn’s disease.
Trial website
NA
Trial related presentations / publications
Oral Presentation Digestive Disease Week ,San Diego May 2012
Public notes

Contacts
Principal investigator
Name 34753 0
Address 34753 0
Country 34753 0
Phone 34753 0
Fax 34753 0
Email 34753 0
Contact person for public queries
Name 18000 0
Dr.Zubin Grover
Address 18000 0
QCMRI
RCH Foundation building
Herston Road
Herston
4006
Brisbane
QLD
Country 18000 0
Australia
Phone 18000 0
+61-736368015
Fax 18000 0
+61736363472
Email 18000 0
[email protected]
Contact person for scientific queries
Name 8928 0
Dr.Zubin Grover
Address 8928 0
QCMRI
Herston Road
Herston
4006
Brisbane
QLD
Country 8928 0
Australia
Phone 8928 0
+61736368015
Fax 8928 0
+61736363472
Email 8928 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseEarly mucosal healing with exclusive enteral nutrition is associated with improved outcomes in newly diagnosed children with Luminal Crohn's disease.2016https://dx.doi.org/10.1093/ecco-jcc/jjw075
EmbasePredicting endoscopic Crohn's disease activity before and after induction therapy in children: A comprehensive assessment of PCDAI, CRP, and fecal calprotectin.2015https://dx.doi.org/10.1097/MIB.0000000000000388
N.B. These documents automatically identified may not have been verified by the study sponsor.