Results of a double-blind, randomized study to evaluate the efficacy and safety of Antibiophilus® in patients with radiation-induced diarrhoea

BACKGROUND AND AIMS: Gastrointestinal toxicity is frequently observed during radiotherapy for malignancies in the abdomen and pelvis. This study was performed to determine the efficacy and tolerability of Lactobacillus rhamnosus (Antibiophilus) in comparison to placebo in a double-blind trial design. Its aim was to determine any clinically relevant difference between Antibiophilus and placebo in terms of efficacy in patients suffering from mild to moderate diarrhoea induced by radiation therapy. METHODS: The study was performed in two radiotherapy units in Hungary; the results are based on the data for 206 recruited patients. RESULTS: Based on statistical analysis, Antibiophilus patients showed superiority with respect to the number of bowel movements (P < 0.10) and faeces consistency ratings by the investigators (P < 0.05) at the study end. Statistical analysis of the patients' self-ratings with regard to diarrhoea grade and faeces consistency showed a statistically highly significant treatment-by-time interaction (P < 0.001) which was supported by the evidence of tendencies or P values below the nominal 5% level in the second half of this study. CONCLUSIONS: Overall, there was a highly favourable benefit/risk ratio in favour of Antibiophilus.