The INHABIT (synergIstic effect of aNtHocyAnin and proBIoTics in) Inflammatory Bowel Disease Trial: A double-blind randomised controlled trial.

Not Applicable

Recruiting

• Conditions: Mild-moderate Ulcerative Colitis; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12623000630617
• Lead Sponsor: niversity of Wollongong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-06-08
• Last Update Posted: 6 November 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
. Primary outcome is health-related quality-of-life measured through the Inflammatory Bowel Disease Questionnaire - 32 item (IBDQ32) [ The IBDQ32 will be assessed at baseline, 6-weeks and 12-weeks post-intervention commencement. <br>The primary timepoint is baseline to 12-weeks post intervention commencement. <br>]