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. 2020 Mar 4;2020(3):CD007443. doi: 10.1002/14651858.CD007443.pub3

Zocco 2003.

Study characteristics
Methods RCT (abstract only)
Setting: not stated
Study period: not stated
Participants Inclusion: inactive UC and quiescent Crohn's disease*
Exclusion: not stated
Age (mean): 32 years
Sex (M/F): 20/16
Site of disease: not stated
Use of medication: not stated
Length of time remission at study entry: not stated
Number randomised (n = 36): 12 (probiotic)/10 (mesalazine)/14 (probiotic + mesalazine)
Number assessed: 12 (probiotic)/10 (mesalazine)/14 (probiotic + mesalazine)
Postrandomisation exclusion: none
Interventions
  • Probiotic alone: Lactobacillus GG 18 X 109 viable bacteria per day (Giflorex, Errekappa, Euroterapic, SpA, Milan, Italy)

  • Probiotic + mesalazine: Lactobacillus GG 18 X 109 viable bacteria and mesalazine 2.4 g per day

  • Mesalazine 2.4 g per day

Outcomes Duration of follow‐up: 12 months
  • Relapse (defined by clinical and endoscopic features. No further details)

  • Withdrawal due to adverse events

Notes Funding source: not stated
Declaration of interest: not reported
Data from participants with CD were discarded due to the limited scope of the review.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Participants were reportedly randomised, however, no further details were available
Allocation concealment (selection bias) Unclear risk Not stated
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Not stated
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk Not stated
Incomplete outcome data (attrition bias)
All outcomes Low risk All participants appear to have been accounted for
Selective reporting (reporting bias) Unclear risk The study was published as an abstract. Insufficient information to make a judgement
Other bias Unclear risk The study was published as an abstract. Insufficient information to make a judgement