ACTRN12621001568808Recruiting未知
Examining diet As Therapy in Ulcerative Colitis: a randomised placebo controlled dietary advice trial in adults with mild-moderately active ulcerative colitis (EAT-UC RCT)
Central Adelaide Local Health Network0 sites52 target enrollmentStarted: November 18, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Recruiting
- Sponsor
- Enrollment
- 52
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Randomised controlled trial
- Primary Purpose
- Treatment
- Masking
- Blinded (masking used)
Eligibility Criteria
- Ages
- 18 Years to o limit (—)
- Sex
- All
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).
- •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
Investigators
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