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. 2019 Feb 7;2019(2):CD012730. doi: 10.1002/14651858.CD012730.pub2

Prantera 2012.

Methods Randomized, double blind, placebo controlled
Intention to treat not performed
Twenty‐four week trial
Participants Patients aged 18‐75, active ileal or colonic CD (CDAI 220‐400) (N = 402)
Interventions Randomized to oral rifaximin 400 mg BID (n = 104), oral rifaximin 800 mg BID (n = 98), oral rifaximin 1200 mg BID (n = 99) or oral placebo (n = 101)
Outcomes Primary outcome: Clinical remission (CDAI < 150) at 12 weeks
Secondary outcomes: Number of patients who achieved clinical response at week 12 (reduction in CDAI score of 100 points), number of patients who maintained clinical remission at week 14 and 24 and number of patients with treatment failure (failure to achieve loss of at least 70 in CDAI score after 1 month, or an increase in CDAI score of >100 points from the baseline)
Notes  
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computerized randomisation procedure
Allocation concealment (selection bias) Low risk Centralized randomization using an Interactive Voice Response System
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Double‐blind
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Questionaires used to collect outcomes
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk High rate of withdrawal from the study in each treatment group. (rifaximin 400 mg BID (41/106), rifaximin 800 mg BID (33/99), rifaximin 1200 mg BID (41/103) or placebo (43/102)
Selective reporting (reporting bias) Low risk All expected outcomes were reported
Other bias Low risk No other apparent sources of bias