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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12619000895189

Enrollment

155

Registered

2019-06-26

Start date

2026-09-02

Completion date

2027-09-02

Last updated

2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

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.

Interventions

Treatment arm: Participants will be asked to take one gelatine capsule with 10^9 CFU of the probiotic Bifidobacterium catentulatum morning and evening (two per day) for 8 weeks in their own homes. These will be provided fortnightly by a research coordinator. Adherence will be monitored with a diary recorded by the participant and monitored weekly.

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

Inclusion criteria

1. Patients with an ileal J pouch for ulcerative colitis functioning for at least 3 months. 2. Living within the catchment of the five identified DHBs (Southern, Canterbury, Capital and Coast, Waikato and Auckland).

Exclusion criteria

1. Age <18 years 2. Participant too unwell to answer questionnaires (for example is known to have dementia).

Outcome results