Delia 2007.

Methods	Study design: parallel‐group RCT Duration of the study: 1995 to 2005 Follow‐up: "The study subjects were followed up weekly during the scheduled cycle of radiation therapy and then 1 month after completion of radiation therapy" Country: Italy
Participants	Participants received adjuvant postoperative radiotherapy after surgery for sigmoid, rectal, or cervical cancers and had no contraindication for probiotic or antibiotic therapy or radiotherapy Median age, years: not reported Sex: not reported "The randomization was balanced between treatment groups in terms of sex, age, nodal involvement, tumor grade and size, local invasion at operation, invasion of contiguous structures at histology, and postoperative complications"
Interventions	Intervention (n = 245): VSL#3 (VSL Pharmaceuticals, Fort Lauderdale, MD) Control (n = 245): VSL#3‐identical‐appearing placebo Radiotharapy: total X‐ray dose between 60 and 70 Gy
Outcomes	Incidence and severity of radiotherapy‐induced diarrhoea, time from start of the study to use of loperamide as rescue medication, daily number of bowel movements
Notes
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Randomised study, yet method of randomisation not described
Allocation concealment (selection bias)	Unclear risk	Method of allocation not described
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Double‐blind, placebo‐controlled trial
Blinding of outcome assessment (detection bias) Subjective outcomes	Low risk	Double‐blind, placebo‐controlled trial: low risk for assessment of subjective outcomes
Blinding of outcome assessment (detection bias) Objective outcomes	Low risk	Double‐blind, placebo‐controlled trial: low risk for assessment of objective outcomes (mortality)
Incomplete outcome data (attrition bias) Subjective outcomes	High risk	Intervention group (n = 2 dropouts): 1 participant withdrew his consent after the first session of radiotherapy, and 1 died of myocardial infarction after 3 sessions of radiotherapy; both participants were excluded from analysis of results Control group (n = 6 dropouts): 6 participants were withdrawn after a few sessions of radiotherapy owing to the occurrence of severe diarrhoea resistant to loperamide and the usual standard of care; these participants were excluded from analysis of results. No intention to treat
Incomplete outcome data (attrition bias) Objective outcomes	High risk	Intervention group (n = 2 dropouts): 1 participant withdrew his consent after the first session of radiotherapy, and one died of myocardial infarction after 3 sessions of radiotherapy; both participants were excluded from analysis of results Control group (n = 6 dropouts): 6 participants were withdrawn after a few sessions of radiotherapy owing to the occurrence of severe diarrhoea resistant to loperamide and the usual standard of care; these participants were excluded from analysis of results. No intention to treat
Selective reporting (reporting bias)	Unclear risk	No study protocol was available, but all outcomes prespecified in the methods section were reported in the results section
Other bias	Low risk	No indications of other bias