Table 1 Randomized clinical trials
References | Design | N | Dose | Control | Treatment | Wash-out | Run-in | Challenge | Outcome |
|---|---|---|---|---|---|---|---|---|---|
Biesiekierski [84] | DB-RCT | 34 | 16 g/days | GF bread or muffin | 6 weeks | No data | – | Muffins/bread slices | IBS-triggered by gluten challenge |
Carroccio [14] | DBPC | 50 | 10 g/days | Xylose | 2 weeks | 1 weeks | 4 weeks elimination | Capsules wheat | GS-Symptoms triggered by wheat |
Biesiekierski [85] | DB, cross-over | 22 | 16 g/days | Gluten-low (2 g/days), placebo | 2 weeks | 2 weeks | 6d GFD, 2 weeks low FODMAP | Gluten-rich meals | No symptoms by gluten challenge |
Di Sabatino [86] | DBPC, cross-over | 61 | 4.4 g/days | 1 weeks | 1 weeks | GFD | Capsules gluten | IBS-triggered by gluten challenge | |
Shahbazkhani [87] | DBPC | 72 | 50 g/days | Sachet powder rice flour | 6 weeks | No data | GFD 6 months | Sachet gluten meal | IBS-triggered by gluten challenge |
Zanini [88] | DBPC, cross-over | 35 | 10 g/days | Sachet GF-flour | 10 days | 2 weeks | GFD > 3 months | Sachet gluten | IBS-triggered by gluten challenge |
Zanwar [89] | DBPC | 60 | No data | GF bread | 4 weeks | No data | GFD 1 months | Bread | IBS-triggered by gluten challenge |
Elli [90] | DBPC, cross-over | 98 | 5.6 g/days | Rice starch | 7 days | 7 days | GFD × 3 weeks | Capsules gluten | IBS-triggered by gluten challenge |
Skodje (2017) [91] | Open challenge | 56 | 120 g/days | No control | 3–14 days | No data | GFD 16 months | Bread | GS-Symptoms triggered by wheat |
Skodje [61] | DBPC, cross-over | 59 | 5.7 g/days | GF low FODMAP muesli | 7 days | 7 days | GFD > 6 months | Muesli bars gluten + FOS | IBS-triggered by fructan challenge |
Dale [92] | DBPC | 20 | 11 g/days | Rice starch | 4 days | 3 days | GFD 6 weeks | Muffin gluten | IBS-triggered by gluten challenge |