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. 2020 Jul 17;2020(7):CD006634. doi: 10.1002/14651858.CD006634.pub3

Schultz 2004.

Study characteristics
Methods Study design: randomised, double‐blind, placebo‐controlled trial
Setting: University of Regensburg (Regensburg, Germany)
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)
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
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
Notes Funding source: partly funded by Deutsche Morbus Crohn und Colitis ulcerosa Vereinigung e.V. (DCCV)
Conflicts of interest: none declared
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.