Table 1 Summary characteristics of included studies.
Source | Study design | Trial ___location | No. of centers | Study initiation year | Age (y) | No. of participants | Sex (Female%) | Diagnostic criteria | Active treatment | Administration | Run-in period (wk) | Duration of therapy (wk) | number of visits | outcome assessor | outcome | Response rate (%) | Outdrop rate (%) | ITTA | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mode | Dosing | ||||||||||||||||||
Kline et al.24 | Parallel | North America | 3 | 1997 | 12 | 21 | NR | Manning/ Rome II | PO | Capsule | 3 | / | 2 | 2 | Physician | IR | 43 | NR | No |
Bausserman et al.25 | Parallel | North America | 1 | 2003 | 12.4 | 25 | 84.0 | Rome II | LGG | Capsule | 2 | / | 6 | 2 | Patient | IR | 40 | 21.9 | No |
Gawrońska et al.26 | Parallel | Europe | 1 | 2003 | 11.2 | 19 | NR | Rome II | LGG | Capsule | 2 | 4 | 4 | 2 | Patient | IR; DR; PS | 31.6; 5.3 | 0 | Yes |
Bahar et al.27 | Parallel | North America | 1 | 2002 | 14.2 | 17 | NR | Rome II | AMI | Capsule | 1 | 2 | 8 | 5 | Patient | IR | 0 | 0 | NR |
Handen et al.28 | Parallel | North America | 12 | 2005 | 6.2 | 31 | 19.4% | Rome II | OHIG | Capsule | 2 | 2 | 12 | 4 | Parent | IR | 45.2 | 20 | Yes |
Francavilla et al.29 | Parallel | Europe | 9 | 2004 | 6.3 | 38 | NR | Rome II | LGG | Powder | 2 | 4 | 8 | 3 | Parent | IR | 44.7 | NR | Yes |
Guandalini et al.30 | Crossover | Mixed continent | 5 | 2006 | 12.5 | 59 | 47.5 | Rome II | VSL#3 | Powder | 1/2 | 2 | 6 | 9 | Patient or parent | IR | 33.9 | 11.9 | No |
Romano et al.31 | Parallel | Europe | 1 | 2010 | 13.1 | 30 | 63.3 | Rome III | PHGG | Liquid | 1 | / | 4 | 4 | Patient | IR | 6.7 | 0 | NR |
Kianifar et al.32 | Parallel | Asia | 1 | 2012 | 7.3 | 26 | 50 | Rome III | LGG | Capsule | 2 | / | 4 | 5 | Physician | PS | NR | NR | No |
Parallel | North America | 1 | 2009 | 13.5 | 47 | 61.7 | Rome III | PF | Powder | 1 | 3 | 6 | 2 | Patient | PS | NR | 9.6 | No | |
Giannetti et al.35 | Crossover | Europe | 2 | 2014 | 11.2 | 48 | 56.3 | Rome III | Bifidobacteria | Powder | 1 | 2 | 6 | 9 | Patient | DR | 14 | 4 | Yes |
Sudha et al.36 | Parallel | Asia | 2 | 2014 | 7.89 | 69 | 46.4 | Rome III | BCUIS2 | Chewable tablet | 1 | 2 | 8 | 4 | Patient or parent | IR | 21.7 | 10.4 | No |
Rahmani et al.37 | Parallel | Asia | 1 | 2017 | 7.7 | 15 | NR | Rome III | LR | Chewable tablet | 2 | / | 4 | 2 | Parent | DR; PS | 0 | NR | No |
