Treating adult Crohn's disease with exclusive enteral nutrition using a protocolised approach

Not Applicable

Recruiting

• Conditions: Crohn's Disease; Oral and Gastrointestinal - Crohn's disease

• Registration Number: ACTRN12622000449730
• Lead Sponsor: Central Adelaide Local Health Network (CALHN)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-03-22
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Individuals with a formal diagnosis of Crohn’s Disease which may include histology consistent with CD, clinical diagnosis of active CD or disease visible by endoscopy or radiology or an elevated FC.
2. Active Crohn’s Disease as assessed by the treating clinician as demonstrated by:
A. Clinical evidence with CDAI score > 150 AND/OR
B. Radiological evidence with GIUS or magnetic resonance enterography (MRE) demonstrating active disease AND/OR
C. Biochemical evidence with FCP > 100 microg/g
3. Individuals under the care of an IBD Service and Gastroenterologist across the Central Adelaide Local Health Network (CALHN)
4. Provide informed consent to participate in the study

Exclusion Criteria

1.Individuals with significant medical or cognitive/psychiatric comorbidities that would impair ability to provide consent, consistently adhere to treatment or complete questionnaires required for study outcome measures
2.Individuals where EEN was prescribed for indications of pre-surgical optimisation or downgrading of disease prior; management of abdominal abscess
3.Individuals whose cause of symptoms is deemed to be infectious, iatrogenic or unrelated to underlying pathology of Crohn’s disease
4.Individuals with severe co-morbidities as judged by the treating clinician

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composite outcome: percentage of patients with:<br>1.Clinical response as measured by Crohn's disease activity index (CDAI) reduction of greater than 100 points from baseline OR clinical remission as measured by CDAI less than 150 points <br>AND/OR<br>2.Objective response OR remission as demonstrated by one of:<br> a.Gastrointestinal ultrasonographic (GIUS) response as defined as greater than or equal to 25% bowel wall thickness (BWT) reduction from baseline (mm) OR<br> b.GIUS remission as defined as all of: BWT normalisation, colour Doppler signal less than or equal to 1, normal echo stratification, and absence of inflammatory fat OR<br> c.Biochemical response as defined as faecal calprotectin (FCP) level reductions of greater than or equal to 50% from baseline OR<br> d.Biochemical remission defined as FCP levels less than 100 microg/g<br>[6 weeks aftering starting treatment]