Summary of clinical trials evaluating efficacy of the low FODMAP diet in patients with IBS
| Study design | Inclusion criteria | Low FODMAP | Comparator | Duration of the trial | Results | Reference |
|---|---|---|---|---|---|---|
| Single-blind, randomised cross-over | Healthy subjects (n=15) and patients with IBS (n=15) | All food provided with low FODMAP content (9 g/day) | All food provided with high FODMAP content (50 g/day) | 2 days of interventions with 7-day washout | Abdominal symptoms and lethargy greater with the high FODMAP diet in IBS (p=0.002). Only increased flatus production in health controls | Ong et al62 |
| Non-randomised comparative | Patients with IBS (n=72) | Dietitian-taught low FODMAP diet | Dietitian-taught standard diet | Assessed by questionnaire at follow-up dietetic appointment | Satisfaction with IBS symptoms 76% with low FODMAP diet vs 54% with standard diet; composite symptom score 86% vs 49% (p<0.001); improvements in bloating 82% vs 49% (p=0.002), abdominal pain 85% vs 61% (p=0.023); flatulence 87% vs 50% (p=0.001). | Staudacher et al68 |
| Single-blind randomised | Patients with IBS | Dietitian-taught low FODMAP diet (n=19) | Habitual diet (n=22) | 4 weeks | Adequate control of symptoms 68% of 19 for low FODMAP diet vs 23% of 22 with habitual diet (p=0.005) | Staudacher et al69 |
| Prospective observational | Patients with IBS (n=90) | Dietitian-taught low FODMAP diet | Nil | Mean 15.7 months | 72% satisfied with symptom response via questionnaire; 76% adherent to the diet | De Roest et al72 |
| Single-blind, randomised cross-over | Patients with IBS who fulfilled Rome III criteria for IBS (n=30). Healthy controls (n=8) | All food provided with low FODMAP content | All food provided with FODMAP content similar to estimated content of a typical Australian diet | 3 weeks for each dietary intervention with at least 3 weeks washout between | For the low FODMAP diet ▸ Lower abdominal symptoms than typical FODMAP diet (p<0.001) ▸ Improved symptoms compared with habitual diet during run-in (p<0.001) ▸ 70% showed clinically significantly improvement | Halmos et al67 |
| Consecutive prospective observational | Patients with IBS (Rome III; n=19) | e-health-delivered low FODMAP diet | Habitual diet | 6 weeks habitual diet followed by 6 weeks low FODMAP diet | Improvement in symptoms and quality of life with low FODMAP diet | Pederson et al70 |
| Non-blinded randomised placebo-controlled | Patients with IBS (Rome III) | e-health-delivered low FODMAP diet (n=42) | Probiotic+habitual diet (n=41); and habitual diet alone (n=40) | 6 weeks | Low FODMAP diet superior to placebo (p<0.01), but not to probiotic (p=0.20); probiotic not superior to placebo (p=0.13) | Pederson et al71 |
FODMAPs, fermentable oligo-di-monosaccharides and polyols.