None listed
Conditions
Brief summary
This is a pilot dietary intervention study involving an 8-week dietary intervention prescribed in addition to standard therapy for patients with mild-moderately active ulcerative colitis. People who meet the inclusion criteria and who provide informed consent will be provided with a Dietitian administered meal plan for the study period. Tolerance of and adherence to the prescribed diet will be assessed, along with the nutritional adequacy of the diet. The impact of the diet on luminal intestinal inflammation will be assessed, as well as its effect on the gut microbiome.
Interventions
8-week dietary advice trial where a nutritionally balanced dietary intervention is prescribed through verbal and written instruction by a Dietitian at the start of the 8 week intervention with follow up and dietary support available throughout the trial and during reviews at the end of week 1 and 4. The diet is an adjuvant therapy for people with mild-moderate Ulcerative Colitis, delivered in an outpatient setting. Dietary advice to be provided includes practical strategies to nutritionally bal
8-week dietary advice trial where a nutritionally balanced dietary intervention is prescribed through verbal and written instruction by a Dietitian at the start of the 8 week intervention with follow up and dietary support available throughout the trial and during reviews at the end of week 1 and 4. The diet is an adjuvant therapy for people with mild-moderate Ulcerative Colitis, delivered in an outpatient setting. Dietary advice to be provided includes practical strategies to nutritionally balance diet, reduce preservatives, and modify fermentable fibres.
Sponsors
University of Adelaide
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
Outcome results
None listed