Schultz 2004.
Study characteristics | ||
Methods |
Study design: randomised, double‐blind, placebo‐controlled trial Setting: University of Regensburg (Regensburg, Germany) |
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Participants |
Inclusion: mild‐to‐moderate CD (CDAI 150‐300) Exclusion: none listed Age: not reported Sex: not reported Number randomised (n = 11): 5 (Group 1); 6 (Group 2) |
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Interventions |
Group 1: one week of corticosteroids and antibiotics (ciprofloxacin 500 mg bid, metronidazole 250 mg tid), followed by 2 x 109 CFU/day of Lactobacillus rhamnosus strain GG (CAG Functional Foods, Omaha, NE) Group 2: one week of corticosteroids and antibiotics, followed by placebo |
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Outcomes |
Duration of follow‐up: 24 weeks Primary outcome: sustained remission Secondary outcomes 1. Remission 2. Relapse 3. CDAI 4. CRP 5. Tolerability 5. SIde effects |
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Notes |
Funding source: partly funded by Deutsche Morbus Crohn und Colitis ulcerosa Vereinigung e.V. (DCCV) Conflicts of interest: none declared |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | There were no details on random sequence generation and no response to email enquiry. |
Allocation concealment (selection bias) | Unclear risk | There were no details on allocation concealment and no response to email enquiry. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | There were no details on the methods of blinding and no response to email. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | There were no details on whether outcome assessment was blinded and no response to email. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Attrition rates appeared to be low, and balanced, and all attrition was reported. |
Selective reporting (reporting bias) | Low risk | The trial registration/protocol was not available, although the intended outcomes specified in the methods were reported and these were as expected. |
Other bias | Low risk | The groups appeared to be balanced. |