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. 2018 Aug 31;2018(8):CD008831. doi: 10.1002/14651858.CD008831.pub3

Chen 2014.

Methods Study design: randomised controlled trial
Duration of the study, recruitment: 2006 to 2010
Country: China
Participants Participants with colorectal cancer: age, mean ± SD: intervention group: 60.3 ± 17.2, control group: 59.8 ± 18.7
Interventions Intervention (n = 35): combined Clostridium butyricum and Bifidobacterium capsule: 3 capsules, 3 times a day, administered from 5 days before to 7 days after surgery
Control (n = 35): placebo
All participants received intravenous chemotherapy (calcium folinate 300 mg, fluorouracil 500 mg) during surgery
Outcomes Proportions of diarrhoea, all‐cause mortality, several other clinical outcomes (first postoperative exhaust time, first defecation time, incidence of abdominal distension, incidence of systematic inflammatory response syndrome (SIRS), time of intraperitoneal catheter drain, incidence of infection of incisional wound, incidence of pulmonary infection, incidence of urinary tract infection, time of fever, incidence of hypoproteinaemia, length of consumption of antibiotics, length of hospital stay, side effects relevant to drug), biochemical indices
Notes Article written in Chinese
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The random sequence was generated through a random number table
Allocation concealment (selection bias) Unclear risk No relevant information
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Placebo‐controlled trial with similar packaging of capsules
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk Insufficient information for judgement
Blinding of outcome assessment (detection bias) 
 Objective outcomes Low risk No information; however it is unlikely that assessment of objective outcomes (mortality) would have been influenced
Incomplete outcome data (attrition bias) 
 Subjective outcomes Unclear risk Five participants in each group were excluded because of metastasis or non‐adherence to treatment strategy. Reasons for dropout were not specified per group
Incomplete outcome data (attrition bias) 
 Objective outcomes Unclear risk Five participants in each group were excluded because of metastasis or non‐adherence to treatment strategy. Reasons for dropout were not specified per group
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