Table 2.
Assessment of risk of bias in the studies reviewed
Study | Concealment of randomization | RCT stopped early | Patients blinded | Healthcare providers blinded | Data collectors blinded | Outcome assessors blinded | Reporting drop-out or withdrawal | Other potential bias | Selective outcome reporting | Jadad score |
---|---|---|---|---|---|---|---|---|---|---|
Lahti et al. 2013 [22] | Yes | No | Yes | Yes | Yes | No | Yes | No | No | 4 |
Rampelli et al. 2013 [23] | Yes | No | Yes | Uncleara | Uncleara | Uncleara | Unclear | Yesc | Yesc | 3 |
Ferrario et al. 2014 [27] | Yes | No | Yes | Uncleara | Uncleara | Uncleara | Yes | No | No | 3 |
Bjerg et al. 2015 [19] | Yes | No | Yes | Yes | Yes | Yes | Yes | Yesb | No | 5 |
Brahe et al. 2015 [20] | Yes | No | Yes | No | No | No | Yes | No | No | 4 |
Hanifi et al. 2015 [21] | Yes | No | Yes | Yes | Yes | Yes | Yes | Yesb | No | 5 |
Simon et al. 2015 [24] | Yes | No | Yes | Uncleara | Uncleara | Uncleara | Yes | No | No | 4 |
Based on PRISMA (and Cochrane)’s tools for assessing risk of bias. The Jadad score is a three-item instrument that evaluates likelihood of bias in terms of quality of randomization, quality of blinding, and reasons for withdrawal/drop-out. It is compiled of the following quality items from the table: Concealment of randomization, Patients blinded, Healthcare providers blinded, Data collectors blinded, Outcome assessors blinded, and Reporting drop-out or withdrawal
aDouble-blinded study but unclear whether healthcare providers, data collectors, and outcome assessors were all blinded
bPerformed next-generation sequencing on fecal samples from a subgroup of the included individuals. Bjerg et al. selected 10 (of 32) placebo-treated and 10 (of 32) probiotic-treated participants with the highest triacylglycerol concentration in the blood at week 0. Hanifi et al. selected 20 (all) placebo-treated and 17 (of 20) probiotic-treated participants from the group with the highest dose (10 × 109 colony-forming units) of the probiotic treatment
cNo direct comparison between treatment groups was made for the age-related dysbiosis