EFFECT OF PROBIOTICS ON BOWEL FUNCTION RESTORATION AFTER ILEOSTOMY REVERSAL IN PATIENTS WITH RECTAL CANCER: A DOUBLE-BLIND RANDOMIZED CONTROLLED TRIAL
Jung Rae Cho*, Byung jun Yoon, Heung-Kwon Oh
Department of Surgery, Seoul National University Bundang Hospital, Seongnam, Korea (the Republic of)
This study aimed to determine the efficacy of probiotics for the restoration of bowel functions after ileostomy reversal following low anterior resection in patients with rectal cancer. This study was a pilot, randomized, double-blind, placebo-controlled trial. The probiotics used in this study was derived from kimchi, which contains Lactobacillus plantarum. The patients were randomly allocated to groups receiving probiotics or a placebo once daily from preoperative days 1 to 21. All questionnaires were completed at 1 and 3 weeks after ileostomy repair. The primary outcomes were the Memorial Sloan-Kettering Cancer Centre (MSKCC) Bowel Function Instrument and the low anterior resection syndrome (LARS) scores at 3 weeks postoperatively. The secondary outcomes were measured using the EORTC C3 and CR29 questionnaires. Among the 40 enrolled patients, the primary outcomes were measured in 36 patients (probiotics, n = 17; placebo, n = 19). The MSKCC questionnaire total scores (56.2 ± 12.0 vs. 55.0 ± 10.7, p = 0.356) and LARS scores (33.3 ± 7.6 vs. 36.0 ± 5.3, p = 0.257) were not significantly different between the two groups. In the MSKCC Bowel Function Instrument, the dietary scale score at postoperative 1 week was significantly higher in the probiotic group (13.1 ± 3.8 vs. 9.0 ± 3.0, p < 0.001). The scores based on the other questionnaires were not significantly different between the two groups. Adverse events occurred in 11 patients, but no significant difference was found between the two groups (17.5% vs. 10%, p = 0.480). This pilot study did not show significant results supporting the ability of probiotics for improving bowel function in the patients who had undergone ileostomy reversal. However, considering that the administration of probiotics showed positive results in some subscales, further study is warranted. This study was registered in https://clinicaltrials.gov (No. NCT02751736).
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