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. 2012 Oct 17;2012(10):CD001321. doi: 10.1002/14651858.CD001321.pub5

Ferrara 2009.

Methods
  • Study design: parallel 3 arm RCT

  • Power calculation: no

  • Intention‐to‐treat analysis: no

Participants Inclusion criteria
  • Setting: ambulatory paediatric nephrology clinic; single centre

  • Country: Italy

  • Girls 3‐14 years attending an ambulatory paediatric nephrology clinic; more than 1 UTI in previous 12 months

  • Number: 84 randomised; 80 analysed

  • Mean age: 7.5 years


Exclusion criteria
  • Structural abnormalities; deformities of the urinary tract; impaired kidney function

Interventions Treatment group
  • Cranberry‐lignoberry concentrate

    • Cranberry concentrate: 50 mL/d for 6 months (97.5 g cranberry concentrate)

    • Ligonberry concentrate: 1.7 g in 50 mL water

    • No sugar additives

  • Lactobacillus GG drink: 100 mL on 5 days each month for 6 months (contains 4 x 107 cfu/100 mL)


Control group
  • No treatment

Outcomes
  • Symptomatic UTI (symptoms being frequency, dysuria, urgency, haematuria, nocturia, fever, back or hip pain and ≥ 108 cfu/L

Notes
  • Exclusions post randomisation: 0

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random numbers table
Allocation concealment (selection bias) Unclear risk No details on how well allocation was concealed
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No, girls knew what treatment they were taking
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No details stated
Incomplete outcome data (attrition bias) 
 All outcomes High risk Those lost to follow‐up were excluded, no analysis of best and worst case scenarios
Losses to follow‐up/withdrawals: 4
Selective reporting (reporting bias) Low risk Appropriate outcome
Other bias Unclear risk Details on patients are limited, selection bias may be present
Source of funding: NS