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Prospective assessment of the effects of Exclusive Enteral Nutrition on inflammation, epithelial integrity and body composition in patients with Crohn’s disease

Prospective assessment of the effects of Exclusive Enteral Nutrition on inflammation, epithelial integrity and body composition in patients with Crohn’s disease

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000357459
Acronym
PrEEN
Enrollment
2
Registered
2025-04-24
Start date
2024-10-11
Completion date
2025-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Exclusive enteral nutrition (EEN) is a dietary therapy for the treatment of Crohn's disease (CD) well established in reducing inflammation, particularly in paediatric CD. Gaps in knowledge relating to EEN remain, particularly relating to mechanism of action, impact on body composition, quality of life and adherence, particularly in adult cohorts. This study aims to address many of these gaps in knowledge through prospectively evaluating adult patients commenced on EEN, including objective measures of disease activity (biochemical, sonographic), body composition measures, novel biomarkers, adherence and quality of life over 6 weeks. It is hypothesised that EEN will lead to sonographic response, improvements in body composition and muscle strength as well as clinical symptoms and quality of life

Interventions

Exclusive Enteral Nutrition (EEN) is a dietary therapy used to treat active Crohn's disease. It involves the provision of a specialised liquid nutrition formula (nutritionally complete, fibre free) for 6-8 weeks under the supervision of Inflammatory Bowel Disease (IBD) dietitian and gastroenterologist to reduce intestinal inflammation. Patients who are commencing EEN at our centre as a part of their treatment, will be offered enrolment in the study. The research dietitian calculates estimated

Exclusive Enteral Nutrition (EEN) is a dietary therapy used to treat active Crohn's disease. It involves the provision of a specialised liquid nutrition formula (nutritionally complete, fibre free) for 6-8 weeks under the supervision of Inflammatory Bowel Disease (IBD) dietitian and gastroenterologist to reduce intestinal inflammation. Patients who are commencing EEN at our centre as a part of their treatment, will be offered enrolment in the study. The research dietitian calculates estimated nutrition requirements using equations (that account for weight, gender, age, disease activity and physical activity) and tailors the EEN regime to the estimated requirements (these can be reviewed at each review if there is a change to weight, activity). Participants will be assess at baseline (face-to-face) by the research dietitian and reviewed at week 1, 2, 4 via telehealth/phone with a face-to-face appointment at week 6. Assessment throughout the study comprise anthropometry (including body composition), clinical symptoms, tolerance, adherence, biochemistry and ultrasound. Participants complete a daily diary throughout the study to assess adherence, as well as weekly self reported adherence as per an adherence scale). EEN intervention: 200ml bottles across the day to meet individuals estimated nutrition requirements (ie. 5-8 bottles daily, depending on individual patient characteristics). This is provided to patients via the standard of care processes for accessing EEN at this institution (ordered by the dietitian and sent to patients home).

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients with confirmed diagnosis of Crohn's disease with active inflammation necessitating the use of EEN at Alfred Health (IBD clinic or IUS clinic) and stable medical therapy for previous 2 months

Exclusion criteria

1. Significant medical or cognitive/psychiatric comorbidities that would impair ability to provide consent 2. Ineligibility for Medicare 3. Inability to speak or read English to give informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026