Wildt 2011.

Study characteristics
Methods	Double‐blinded, multicentre RCT Setting*: "two participating centers in Denmark" Study period: June 2004 to March 2006
Participants	Inclusion: age ≥ 18 years; established diagnosis of UC left‐sided disease (endoscopic changes distally to the splenic flexure) ‐ including proctitis; time since relapse > 4 weeks during stable monotherapy with 5‐ASA or no medication at all; ≥ 1 relapse within the last year. Exclusion: pregnancy (postive urine HCG) or breastfeeding; chronic liver or kidney disease; severe chronic disease of vascular or cardiopulmonary aetiology, malignancies; immunosuppressive disease or treatment; inflammatory bowel diseases besides UC, malabsorption syndromes, and former surgical procedures involving the gastrointestinal tract — with the exception of appendectomy. Treatment with azathioprine, 6‐mercaptopurine, biological immunomodifiers, and treatment with steroids within 1 month of entry. Sex (M/F): 10/22 Age (median/range): 37.5 (23 to 68) years Site of disease (location from anal valve ‐ cm): 20 (5 to 70) ‐ probiotic/22.5 (5 to 60) ‐ placebo Use of medication: 24 (5‐ASA orally, rectally and both); 1 (salazopyrine) Length of time remission at study entry: 4 (2 to 9) ‐ probiotic/5 (2 to 11) months ‐ placebo Number randomised: 20 (probiotics)/12 (placebo) Number analysed: 20 (probiotics)/12 (placebo) Postrandomisation exclusion: 1 ‐ pregnancy, however, ITT principle was applied
Interventions	Probiotics: oral preparation containing L acidophilus strain La‐5 and B animalis subsp. lactis strain BB‐12 Placebo. Two capsules taken three times daily for 52 weeks. No other medications for UC were allowed during the study period
Outcomes	Duration of follow‐up: 52 weeks Number maintaining remission (1 year). Remission ‐ presence of two out of three criteria: a simple clinical colitis activity index (SCCAI) score ≤ 4 endoscopically grade 0‐1 (Baron 1964) and/or histologically grade 0‐1 (Truelove 1956) Relapse (reported in the discussion section). Relapse was defined as SCCAI score > 4 and/or endoscopic changes grade 2 to 3 Adverse events (flatulence, abdominal bloating and pain; changes in faecal consistency; musculoskeletal ‐ arthralgia, sacroiliitis; various ‐ tiredness, incontinence, stress, oral blisters, eye dryness; headache, dizziness; influenza, gastroenteritis, cystitis and pneumonia; serious adverse events) Serious adverse events Withdrawal due to serious adverse events
Notes	Funding source: "The study was supported by grants from Chr. Hansen A/S, Hoersholm, Denmark and by grants received from P. Carl Petersens Foundation and The Danish Crohn Colitis Organisation." Declaration of interest: "one of the authors (EB) is employed at the laboratory at Chr. Hansen A/S" *Presumably Gentofte and Hvidovre Hospital, University of Copenhagen Denmark judging by authors' affiliation
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: "...randomised in blocks of 6 according to a table‐generated randomisation list to receive either Probio‐Tec AB‐25 (two capsules three times daily, resulting in a total delivery of 1.5 X 10 11 CFU daily) or to receive placebo (two capsules three times daily) in a 2:1 ratio" Comment: adequate randomisation
Allocation concealment (selection bias)	Unclear risk	Correspondence with author: "At inclusion in the study an enclosed envelope was drawn from a batch of 6 envelopes ‐ and the randomization revealed." Comment: no information as to whether envelopes were opaque and numbered
Blinding of participants and personnel (performance bias) All outcomes	Low risk	Quote: "Placebo medication […] was identical in appearance, size and taste" Comment: adequate blinding
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Trial was referred to as double‐blinded placebo study, however, there were no details on blind outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Low risk	ITT analysis was applied
Selective reporting (reporting bias)	Low risk	Study protocol available (NCT00268164) and all prespecified outcomes were reported
Other bias	High risk	Comment: imbalance in baseline characteristics ‐ there were more participants receiving medication at inclusion in the intervention group compared to the control group (reported P = 0.018).