4. Probiotics vs placebo for treatment of diarrhoea induced by radiotherapy.

Study ID and participants	Intervention(s)	Results
Urbancsek 2001 Participants with cancer who developed diarrhoea within 4 weeks after receiving radiotherapy in the abdominal region	Intervention: Lactobacillus rhamnosus (Antibiophilus, with each sachet containing 1.5 g of Lactobacillus rhamnosus equivalent to 1.5 × 10⁹ colony‐forming units) 3 times a day (n = 102) Control: identical‐appearing sachets of placebo, each containing 700 mg corn starch, 797 mg microcrystalline cellulose, 1.37 mg iron oxide, 1.13 mg dispersed orange (colouring agent), and 1 mg caramel aroma 3 times a day (n = 103)	Proportion of participants with diarrhoea: not reported Quality of life: not assessed Severity of diarrhea: average grade rated by investigators using standard scores of 0 for none, 1 for mild, 2 for moderate, and 3 for severe diarrhoea: Study start: 2.0 versus 2.2 Study end: 0.7 versus 1.0 Time (hours) to rescue medication for diarrhoea: 138 (SE = 5) versus 125 (SE= 5) (MD 13, 95% CI ‐0.86 to 26.86) Proportion of participants requiring rescue medication for diarrhoea: RR 0.74, 95% CI 0.53 to 1.03 Adverse events: "Serious adverse events (in GCP terms) were not observed in this study. In both study groups, three participants reported adverse events. In the Antibiophilus1 group, three participants reported gastrointestinal problems (mild to moderate); in the placebo group, two participants reported gastrointestinal events (moderate to severe), and one patient observed a mild labial oedema. All documented events were of a transient nature; in three patients, symptomatic treatment of adverse events was prescribed" Mortality: study authors reported no deaths

CI: confidence interval.

GCP: Good Clinical Practice.

MD: mean difference.

RR: risk ratio.