Abstract # 1001 A Double-blind, Multicenter, Randomized, Placebo-controlled Nutritional Trial Of The Efficacy Of Fermented Milk With The Probiotic Lactobacillus Casei Dn-114001 In Preventing Radiation-induced Diarrhea In Patients With Gynecologic Cancer Treated With Pel

Presenter: Giralt, Jordi

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Results:
A total of 145 patients were screened, 118 of them were eligible and were included and randomly assigned (ITT population). Thirty-three patients were excluded from the study. Causes were: protocol violations (n=17), patientís decision (n=11) and lack of compliance (n=5). Eighty-five patients were assessable per protocol (PP population). Analyses of the ITT and PP populations were performed, but the abstract only includes data on PP analysis. Both groups were well balanced and there was no significant difference in patient characteristics. The study product was well tolerated and no relevant side-effects were recorded. Grade ≥ 2 were observed in 24 out of 41 patients in the placebo group and 30 out of 44 in the probiotic group (p=0.099). Median time to present grade 2 diarrhea was 31 days and 30 days respectively. Patients treated with loperamide were 36% and 29% respectively (p=0.075). Probiotic treatment had a significant effect on stool consistency as manifested by a delayed onset of liquid stools, 14 days for probiotic versus 10 days for placebo (p=0.048). Pathological increase of fecal calprotectin was observed in 3 of 11 placebo, and in 1 of 12 probiotic patients. Basal and week 7 values of EORTC QLQ-C30 questionnaire showed no differences in quality of life.




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