Trial Details

Recruiting
Basic Information
Clinical ID c2180
Identifier ACTRN12623000630617
Trial Title The INHABIT (synergIstic effect of aNtHocyAnin and proBIoTics in) Inflammatory Bowel Disease Trial: A double-blind randomised controlled trial assessing faecal calprotectin, gut microbiota profile and quality-of-life.
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Mild-moderate Ulcerative Colitis ; Mild-moderate Ulcerative Colitis ;Oral and Gastrointestinal - Inflammatory bowel disease
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 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. <br
Participant Information
Sponsor University of Wollongong
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, ELDER, OLDER_ADULT
Study Design
Study Type Interventional
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -