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Bowel Stimulation Before Loop Ileostomy Closure Using Probiotics: A Study Protocol for a Randomized Controlled Trial at a Single Center
ABSTRACT
Background:
Rectal cancer patients who undergo sphincter-preserving surgery often develop low anterior resection syndrome (LARS), characterized by symptoms such as fecal incontinence and irregular bowel movements, often due to surgical injury and altered pelvic anatomy. Diverting ileostomy can exacerbate gut microbiota imbalances and increase harmful microbes.
Objective:
This study aims to assess the safety and efficacy of probiotics administration prior to ileostomy closure to manage LARS.
Methods:
This single-center, randomized controlled trial will include patients with clinical stage II–III rectal cancer who underwent total mesorectal excision and diverting ileostomy following neoadjuvant chemoradiotherapy. Participants will be randomly allocated to receive either 250 mL of normal saline with 4 g of Lacidofil® or normal saline alone via the distal limb of the ileostomy once daily for 2 weeks before closure. The primary outcome is the LARS score 3 months after ileostomy closure. Secondary outcomes include postoperative complications, bowel recovery, and hospital stay.
Results:
The study was approved by the Keimyung University Dongsan Medical Center IRB (DSMC-2024-03-016) and registered in the Clinical Research Information Service (CRIS 20250825-004). Recruitment will begin in March 2026, with completion anticipated by March 2029. As of submission, the trial is in the pre-enrollment phase, with no data analysis yet performed. Results are expected to be available and published by mid-2029.
Conclusions:
This trial will provide evidence on whether probiotic bowel stimulation before ileostomy closure improves bowel function and alleviates LARS after rectal cancer surgery. Clinical Trial: Clinical Research Information Service 20250825-004. Registered on 25 August 2025.
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