Efficacy of enteral nutrition in adult Ileal Crohn's disease- the RICE study

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

• Registration Number: ACTRN12616000251426
• Lead Sponsor: Concord Hospital, Department of Gastroenterology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-02-23
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Participant must meet all of the inclusion criteria below at time of enrolment to be eligible to participate in phase 1 of the study
1.Crohn’s disease involving the terminal ileum, established diagnosis >6 months
2.Aged 18 – 70 inclusive
3.Ileal complicated Crohn’s disease requiring laparoscopic / open ileal (or small bowel segmental) resection, OR severe ileal Crohn’s disease

Participant must meet all of the inclusion criteria below at time of surgery to be eligible to participate in phase 2 of the study:
1.Crohn’s disease involving the terminal ileum, established diagnosis >6 months
2.Aged 18 – 70 inclusive
3.Ileal complicated Crohn’s disease undergoing laparoscopic / open ileal (or small bowel segmental) resection
4.Terminal ileum can be reached by colonoscopy.

Exclusion Criteria

Participant must not meet any of the exclusion criteria below at time of enrolment to be eligible to participate in either phase 1 or phase 2 of the study
1.Unable to consent, comply or complete the study and associated procedures (such as understanding of questionnaires)
2.Requirement for emergency small bowel resection eg. those with uncontrolled sepsis or peritonitis or complete bowel obstruction
3.Short bowel syndrome or any other significant gastrointestinal disease (eg irritable bowel syndrome, active neoplasm, diverticulitis etc)
4.Colectomy, stoma formation ie. non-primary anastomosis, or strictureplasty without small bowel resection
5.Resection for malignancy or known colorectal dysplasia (apart from polyps that have been completely removed)
6.Pregnancy, lactation or unwillingness to practice an effective method of contraception during the study period
7.Ulcerative colitis or IBD unclassified
8.Comorbidity or psychiatric disorder sufficiently severe to jeopardize participation

Study & Design

• Study Type: Interventional
• Study Design: Not specified