None listed
Conditions
Brief summary
Inflammatory Bowel Disease (IBD) is a chronic gastrointestinal disease, affecting approximately 1 in 250 Australians. Ulcerative colitis is a sub-type of IBD. Scientific research exploring the effectiveness of nutritional therapies in adults with Ulcerative Colitis has not yet found many definitive conclusion, therefore more research is needed. In addition, research testing how these nutritional therapies change the gut microbiota may be beneficial at developing anti-inflammatory nutritional therapies that help to manage this burdensome disease. There is a lack of clinical trials that have tested both changes to inflammatory markers and the gut microbiota in adults with inflammatory bowel disease, after taking a microbiota-modulating therapy. Plant athocyanins and probiotics have both been shown to reduce inflammation, however not enough to be effective in adults with IBD. In this study, we plan to test for the first time whether combining both an anthocyanin and a probiotic will result in more effective reductions in inflammation and therefore beneficial disease control. This study aims to evaluate the effectiveness of a multi-strain probiotic intervention provided together with dietary anthocyanins extracted from the New Zealand Blackcurrants on the gut microbiota profile and inflammatory biomarkers in adults with mild-moderate Ulcerative Colitis. We hypothesise that the combination of anthocyanins and probiotics will lead to reduction in gut inflammation in participants (measured through faecal calprotectin), and will alter the gut microbiota. We hypothesise that these improvements will be more significant in participants who take the combined intervention (anthocyanin + probiotic) rather than participants who take the anthocyanin alone or probiotic alone.
Interventions
A double-blind randomised controlled trial of 12 weeks duration with four intervention arms containing 25 participants in each: 1) 310mg anthocyanin derived from New Zealand Blackcurrants and placebo probiotic; 2) multi-strain probiotic and placebo fruit powder; 3) 310mg anthocyanin plus a multi-strain probiotic; 4) placebo fruit powder and placebo probiotic.
Anthocyanin intervention: 12g freeze-dried Blackcurrant powder will be consumed daily by participants in intervention arms 1 & 2. This p
A double-blind randomised controlled trial of 12 weeks duration with four intervention arms containing 25 participants in each: 1) 310mg anthocyanin derived from New Zealand Blackcurrants and placebo probiotic; 2) multi-strain probiotic and placebo fruit powder; 3) 310mg anthocyanin plus a multi-strain probiotic; 4) placebo fruit powder and placebo probiotic. Anthocyanin intervention: 12g freeze-dried Blackcurrant powder will be consumed daily by participants in intervention arms 1 & 2. This provides 310mg anthocyanins/day. The product can be mixed in any cold, low acidity, non-carbonated drink or food (ie smoothie, juice, water, milk or on yoghurt or cereal). Probiotic intervention: Participants in intervention arms 2 & 3 will receive a multi-strain probiotic, in the form of two daily sachets. This probiotic contains one strain of Streptococcus thermophilus BT01, three strains of Bifidobacteria (B breve BB02; B animalis subspecies [subsp] lactis BL03, previously identified as B longum BL03; and B animalis subsp lactis BI04, previously identified as B infantis BI04), and four strains of Lactobacilli (L acidophilus BA05, L plantarum BP06, L paracasei BP07, and L helveticus BD08, previously identified as L delbrueckii subsp bulgaricus BD08). This proprietary multi-strain probiotic (VSL#3) contains no less than 450 billion colony-forming units (CFU) per single sachet. The product can be mixed in any cold, low acidity, non-carbonated drink or food (ie smoothie, juice, water, milk or on yoghurt or cereal). Participants will receive the interventions by the research team consisting of dietitians. Participants will be instructed to take the products daily for duration of the trial, with specific intake instructions provided during the first visit. Participants will be required to retain product packaging and return at the final appointment as a measure of adherence.
Sponsors
University of Wollongong
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 No maximum
Healthy volunteers
No
Inclusion criteria
1) diagnosis of Ulcerative Colitis for at least 3 months prior to screening, documented by endoscopic and histologic findings; 2) aged >/= 18 yrs; 3) willing and able to take oral supplements; 4) able to communicate in the English language. As per the Medical Advisor’s recommendation, all participants must have stable medication for 2 weeks prior to commencing the study. All types of IBD medications are permitted in this study. Patients receiving topical therapy (enemas or suppositories) are eligible to participate if they are willing to continue the therapy at a stable dose throughout the study. Participant receiving steroids >20mg/day can commence the study 2 weeks after their dosage has reduced to ?20mg/day. Participants treated with steroids ?20mg/day are eligible to participate if they plan to maintain this stable dose for all the study duration.
Exclusion criteria
Exclusion criteria: 1) Crohn’s Disease; 2) change in antibiotics or probiotics in past 3 months; 3) escalation to biologics or immunomodulators in the past 6 weeks; 4) currently taking steroids >20 mg daily; 5) bowel resection surgery; 6) pregnant and lactating women; 7) end-stage liver or kidney failure; 8) current treatment for C. difficile or other intestinal infections; 9) Sucrose-isomaltose deficiency or maltose intolerance. Participants who require a change in their medication treatment related to uncontrolled UC activity (i.e. increase in steroids or mesalamine doses, start of steroids or biologics or immunosuppressants) during the 12-week intervention, those who do not comply with the study protocol, and those who voluntarily leave the study will not be included in the per-protocol analyses. These participants will be encouraged to continue to complete required outcome data and attend the final visit for inclusion in the intention-to-treat analysis.
Outcome results
None listed