Exploring adjuvant therapy in Ulcerative Colitis

Not Applicable

Completed

• Conditions: lcerative Colitis; Ulcerative Colitis; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12619000063112
• Lead Sponsor: niversity of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-01-17
• Study Completion: 2020-02-10
• Last Update Posted: 24 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

Greater than or equal to 18 years of age with a formal diagnosis of ulcerative colitis
Mild-moderate ulcerative colitis disease activity as defined by a Mayo Score of 3-10 with a Mayo endoscopic sub-score of greater than or equal to 1
Patients on stable therapy (or no therapy) for defined periods:
No therapy for greater than or equal to 4 weeks
Stable dose of oral and/or topical 5-aminosalicylic acid therapy for greater than or equal to 4 weeks
Stable dose of immunomodulator therapy (azathioprine, mercaptopurine, or methotrexate) for greater than or equal to 8 weeks
Stable dose of biologic therapy (infliximab, adalimumab, vedolizumab) for greater than or equal to 12 weeks
Steroid refractory – on <20mg corticosteroids for greater than or equal to 4 weeks

Exclusion Criteria

Quiescent ulcerative colitis disease activity as defined by a 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 Mayo Score of greater than 10 and/or evidence of systemic toxicity (tachycardia, fever, C-reactive protein >40, Haemoglobin <110g/l).
Patients with Crohn’s colitis
Patients who are pregnant or breast feeding
Patients with significant medical or cognitive/psychiatric comorbidities
Patients who have undergone prior colonic surgery
People currently receiving tapering corticosteroid therapy
People with evidence of active infection and/or those requiring current antibiotic therapy
People receiving dual antiplatelet therapy or anticoagulant therapy
People who are unable to provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tolerability of prescribed dietary strategy as measured by 100mm visual analogue scales[8 weeks post commencing the prescribed diet]

Secondary Outcome Measures

Name	Time	Method
Adherence to the prescribed diet using 3-day weighted food diaries and dietary adherence checklists[4 and 8 weeks post commencing prescribed diet];Clinical response - change in Ulcerative Colitis disease activity as defined by a change in Mayo score >= 3 points[8 weeks post commencing prescribed diet];Endoscopic response - change in ulcerative colitis disease activity as defined by a change in Mayo endoscopic sub-score >/= 1 point[8 weeks post commencing prescribed diet];Change in the colonic microbial composition, diversity and function using molecular methods and assessing short chain fatty acids and phenols[4 and 8 weeks post commencing prescribed diet];Change in Food-related quality of life (FRQoL) as defined by validated FRQoL questionnaire[8 weeks post commencing prescribed diet];Nutritional adequacy of prescribed diet using 3-day weighed food diaries and Foodworks9 dietary analysis software[4 and 8 weeks post commencing prescribed diet]