Examining diet As Therapy in Ulcerative Colitis (EAT-UC trial)

Not Applicable

Recruiting

Conditions: lcerative colitis
Ulcerative colitis
Oral and Gastrointestinal - Inflammatory bowel disease

Registration Number: ACTRN12621001568808

Lead Sponsor: Central Adelaide Local Health Network

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 52

Inclusion Criteria

Greater than or equal to 18 years of age with a formal diagnosis of UC
Mild-moderate UC disease activity as defined by a Total Mayo Score of 3-10 with a Mayo endoscopic sub-score of 1 or 2.
Participants on stable therapy (or no therapy) for defined periods of time

Exclusion Criteria

Quiescent UC disease activity as defined by a Total Mayo Score of less than or equal to 2 and/or a Mayo endoscopic sub-score of 0.
Severely active UC as defined by a Total Mayo Score of greater than 10 and/or a Mayo endoscopic sub-score of 3 and/or evidence of systemic toxicity (tachycardia, fever, C-reactive protein greater than 40, Haemoglobin less than 110g/l).
Pregnant
Prior colonic surgery
Crohn's colitis or indeterminate colitis
Corticosteroid therapy (greater than or equal to 20mg oral corticosteroids or any dose IV corticosteroids)
People who habitually follow a vegan or lacto-vegetarian diet
Coeliac disease

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A composite primary outcome of clinical and endoscopic response: a change in UC disease activity between 0 and 8 weeks as defined by a reduction in total Mayo score greater than or equal to 3 points with a reduction in Mayo endoscopic sub score greater than or equal to 1.[ Week 8 post initiation of diet therapy]

Secondary Outcome Measures