Prantera 2006.
| Methods | Randomized placebo controlled trial. Investigators and patients were blinded Intention to treat Twelve week trial |
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| Participants | Patients aged 18‐70 with mild to moderate CD (CDAI 200‐400) (N = 83) | |
| Interventions | Randomized to receive oral rifaximin 800 mg daily (n = 25) and oral placebo, oral rifaximin 800 mg BID (n = 29) or oral placebo BID (n = 29). Other immunosuppressant’s kept at same dose of during study period | |
| Outcomes |
Primary outcome: Clinical remission defined by CDAI ≤ 150 Secondary outcomes: Reduction of CDAI ≥ 70 points from baseline, treatment failure and changes in quality of life (Inflammatory Bowel Disease questionnaire) |
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| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not described |
| Allocation concealment (selection bias) | Unclear risk | Not described |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding of participants and investigators |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Investigators blinded to participant assignment. CDAI and the Inflammatory Bowel Disease Questionnaire (IBDQ) scores were calculated by blinded investigators |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Discontinuation and reasons for withdrawal were fairly even between each group. (rifaximin 800 mg daily and placebo 8/25, rifaximin 800 mg BID 12/29 or placebo BID 13/29) |
| Selective reporting (reporting bias) | Low risk | All expected outcomes were reported |
| Other bias | Low risk | No other apparent sources of bias |