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. 2017 Apr 21;2017(4):CD011384. doi: 10.1002/14651858.CD011384.pub2

Zhu 2014.

Methods Randomised clinical trial
Participants Country: China
Number randomised: 39
Postrandomisation dropouts: not stated
Revised sample size: 39
Average age: 43 years
Women: 18 (46.2%)
Acute interstitial oedematous pancreatitis: not stated
Necrotising pancreatitis: not stated
Mild pancreatitis: 0 (0%)
Moderate pancreatitis: 0 (0%)
Severe pancreatitis: 39 (100%)
Persistent organ failure: not stated
Infected pancreatitis: not stated
Inclusion criteria
  1. People with severe acute pancreatitis

  2. < 48 h from onset of symptoms

  3. < 65 years of age


Exclusion criteria
  1. Chronic pancreatitis

  2. Associated with primary infection, tumours, low immunity

Interventions Group 1: probiotics (n = 20), 2 tablets twice daily for 14 days (Japanese preparation)
 Group 2: placebo (n = 19)
Outcomes Serious adverse events, adverse events, requirement for endoscopic or radiological drainage, infected pancreatic necrosis
Follow‐up: not stated (probably 2 weeks)
Notes Reasons for postrandomisation dropouts: not stated
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Comment: this information was not available.
Allocation concealment (selection bias) Unclear risk Comment: this information was not available.
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Quote: "double‐blind"
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "double‐blind"
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Comment: this information was not available.
Selective reporting (reporting bias) High risk Comment: either mortality or adverse events were not reported.
For profit‐bias Unclear risk Comment: this information was not available.
Other bias Low risk Comment: no other risk of bias

ERCP: endoscopic retrograde cholangiopancreatography; ICU: intensive care unit; IU: international unit; IV: intravenous; KIU: kallikrein inhibitor units; MRC: Medical Research Council (1 MRC = 1 IU); PR: per rectum; SC: subcutaneous.