The Effect of a Probiotic To Improve Ileal Pouch Health: A Randomised Controlled Trial

Aim: To determine if the probiotic Bifidobacterium catentulatum reduces elevated calprotectin levels in patients with an ileal pouch for UC using a double-blinded, randomised, placebo-controlled trial. At least 155 patients will be randomised into one of two groups. One of these groups will receive a gelatin capsule containing 10^9 probiotic bacteria, and the other group will receive an identical gelatin capsule containing a placebo. Randomisation will be computer generated, and the investigators, study coordinator, and patients will be blinded to the treatment group. Both groups will be asked to take a capsule morning and evening for eight weeks. Study participants will be given two weeks of capsules at baseline, then twice weekly until the end of the study. To monitor compliance, the study coordinator will ask each patient to record how many capsules they have taken each day. Missed doses and adverse events will be recorded. Faecal samples and study surveys will be collected at baseline, after 8 weeks of treatment, and 4 weeks post-treatment. These outcomes will be compared between groups to determine the efficacy of the probiotic treatment.