Trial Details

Recruiting
Basic Information
Clinical ID c2641
Identifier ACTRN12619000911190
Trial Title Defining the Australian Inflammatory Bowel Disease Microbiome Study - The AIM Study
Trial URL Visit Original Page
Study Information
Study Results

No results available

Conditions Inflammatory Bowel Disease;ulcerative colitis;colitis;Crohn's disease; Inflammatory Bowel Disease ulcerative colitis colitis Crohn's disease;Oral and Gastrointestinal - Inflammatory bowel disease;Oral and Gastrointestinal - Crohn's disease;Inflammatory and Immune System - Other inflammatory or immune system disorders
Interventions Patients with Inflammatory Bowel Disease Male and female (nonpregnant) patients with either ulcerative colitis or Crohn's disease undergoing follow-up colonoscopy for disease activity assessment will have samples of large bowel mucosa, peripheral blood, urine and stool collected at colonoscopy (stool and urine collection tubes/instructions will be provided in advance, so patients can bring samples to their colonoscopy appointment). IBD patients who are eligible for the study but are not requiring colonoscopy, will be invited to participate in the study by local research teams either at the current clinic visit, a future scheduled clinic visit or a separate visit to the local clinical research facility. At this appointment, peripheral blood, urine oral swab and stool will be collected (stool and urine collection tubes/instructions will be provided in advance, so patients can bring samples to their appointment). All IBD patients will be asked to complete a series of validated questionnaires detailing patient reported outcomes/environmental exposures as well as dietary habits. Completion of the questionnaires will be requested at study entry and at the end of 12 and 24 months. A limited patient reported measure of disease activity will also be requested alongside 3 monthly stool sampling. To allow further detailed analyses of the gut microbiota, patients will be asked to provide oral swab and stool samples, for microbiota analysis and measurement of host protein levels including faecal calprotectin, every 3 months for 24 months. In the event that patients experience an increase in symptoms, they will be advised to contact their IBD clinical team as per usual clinical management, but they will be requested to provide additional oral s
Participant Information
Sponsor University of New South Wales
City -
Country/Region Australia
Enrollment Criteria
Sex Requirement ALL
Age Requirement ADULT, CHILD, ELDER, OLDER_ADULT, TEENAGER
Study Design
Study Type Observational
Phase Not Available
Time Information
Start Date 2025-04-24
Primary Completion Date -
Completion Date -