None listed
Conditions
Brief summary
This is a prospetive, exploratory, randomised, controlled feeding study looking at whether an anti-inflammatory diet can augment treatment response to 5aminosalicylates (firs tline treatment) in ulcerative colitis. Diet may play a role in developing ulcerative colitis (UC) but we don’t know whether diet can be used to treat ulcerative colitis (UC). The aim of this study is to investigate whether the MAID diet can improve response to medications and quality of life for patients with UC. We will also look at whether diet can also help good gut bacteria, produce anti-inflammatory chemicals and reduce gut leakiness.
Interventions
Dietary Intervention:
The Modified Anti-Inflammatory Diet (MAID) will be designed based on the latest evidence for dietary interventions in ulcerative colitis (UC), focusing on high fibre content; low processed and red meats; an increase in fermented foods and minimal food additives and emulsifiers.
Each participant will receive two meals per day (lunch and dinner) for 8 weeks, prepared by a professional chef in a commercial-grade kitchen. Frozen meals will be delivered directly to participant
Dietary Intervention: The Modified Anti-Inflammatory Diet (MAID) will be designed based on the latest evidence for dietary interventions in ulcerative colitis (UC), focusing on high fibre content; low processed and red meats; an increase in fermented foods and minimal food additives and emulsifiers. Each participant will receive two meals per day (lunch and dinner) for 8 weeks, prepared by a professional chef in a commercial-grade kitchen. Frozen meals will be delivered directly to participants' homes to promote adherence and prevent potential biases introduced by self-reported dietary intake. After 8 weeks, participants will be unblinded and offered an appointment with a dietitian during where 30 mins of MAID dietary education will be provided, advising them how to shop, cook, and prepare meals for an 8-week follow-up study. Drug Intervention: 5aminosalicylate treatment oral +/- rectal. Participants in both dietary interventions will be started on an optimal dose of 5aminosalicylate (5ASA) using 3 g orally once daily. Salofalk granules, which will be maintained for the duration of the 16-week study. Patients will be assessed on a weekly basis by the clinical research team. After 4 weeks of treatment, those with no improvement in rectal bleeding and stool frequency (defined as an Simple colitis clinical activity index (SCCAI) score for rectal bleeding greater than or equal to 2 and daytime bowel frequency of greater than or equal to 1. ) can have topical 5-ASA therapy added to the existing oral regimen. This topical 5-ASA regimen must be either Salofalk 1g foam or Salofalk 1g suppositories, based on the patients UC phenotype. The Salofalk granules regimen will be maintained at 3g per day, even if this topical therapy is added. Adherence monitoring: Dietary Diaries: Baseline dietary intake will be recorded using a 3-day diet diary, completed via the Easy Diet Diary app (Xyris Software Australia Pty Ltd 2020) or a paper diary, based on participant preference. A second 3-day diet diary will be completed during week 16 to monitor dietary adherence. Dietary intake will include household serves and weighed food measurements including details about ingredients, brands of food and cooking methods. During week 0 to 8 a weekly diet checklist will be completed. Adherence Monitoring: The use of meal delivery services and dietary diaries will help promote high adherence to the intervention and accurately assess dietary compliance. Adherence to drug therapy will primarily be monitored by asking participants to bring their remaining medication to their week 8 and week 16 study visits. A member of the study team will count the remaining packs and compare this with the number issued at the baseline visit.
Sponsors
RBWH, Metro North Health Services
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
i) Provide signed and dated informed consent ii) Willing to comply with all study procedures and be available for the duration of the study iii) Age greater than or equal to 18 years old, less than or equal to 65 years old iv) New diagnosis of UC v) Mild-moderately active UC as assessed by a baseline Ulcerative Colitis Endoscopic Index of Severity (UCEIS) score 2-6 vi) All patients will be treatment naïve vii) BMI 35kg/m2 viii) Renal function and liver function acceptable for initiation and continuation of mesalazine during study period (liver function: AST ALT 60ml/min).
Exclusion criteria
i) Severe ulcerative colitis with SCCAI greater than or equal to 8 OR UCEIS greater than or equal to 7 OR hospitalization for acute severe colitis (ASUC) in the previous 6 months ii) Crohn's disease and indeterminate colitis iii) Pregnancy or lactation iv) Active infection v) Exposure to antibiotics, probiotics, prebiotics, corticosteroids or other therapies known to affect gastrointestinal function (including laxatives, fibre supplements, proton pump inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs)) within 4 weeks of enrolment. vi) Individuals who are malnourished, as determined by an overall Subjective Global Assessment (SGA) rating of B or C. vii) Individuals who are not able to comply with the dietary intervention such as individuals who are vegetarian, vegan or adhere to a restrictive dietary pattern. viii) Individuals not willing to co-recruit into the Australian IBD Microbiome (AIM) study ix) Diverticular disease (defined as a confluent segment of diverticula between the proximal rectum and the distal descending colon with luminal distortion).
Outcome results
None listed