Table 2

Summary of clinical trials evaluating efficacy of the low FODMAP diet in patients with IBS

Study designInclusion criteriaLow FODMAPComparatorDuration of the trialResultsReference
Single-blind, randomised cross-overHealthy 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 washoutAbdominal symptoms and lethargy greater with the high FODMAP diet in IBS (p=0.002). Only increased flatus production in health controlsOng et al62
Non-randomised comparativePatients with IBS (n=72)Dietitian-taught low FODMAP dietDietitian-taught standard dietAssessed by questionnaire at follow-up dietetic appointmentSatisfaction 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 randomisedPatients with IBSDietitian-taught low FODMAP diet (n=19)Habitual diet (n=22)4 weeksAdequate control of symptoms 68% of 19 for low FODMAP diet vs 23% of 22 with habitual diet (p=0.005)Staudacher et al69
Prospective observationalPatients with IBS (n=90)Dietitian-taught low FODMAP dietNilMean 15.7 months72% satisfied with symptom response via questionnaire; 76% adherent to the dietDe Roest et al72
Single-blind, randomised cross-overPatients with IBS who fulfilled Rome III criteria for IBS (n=30).
Healthy controls (n=8)
All food provided with low FODMAP contentAll food provided with FODMAP content similar to estimated content of a typical Australian diet3 weeks for each dietary intervention with at least 3 weeks washout betweenFor 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 observationalPatients with IBS (Rome III; n=19)e-health-delivered low FODMAP dietHabitual diet6 weeks habitual diet followed by 6 weeks low FODMAP dietImprovement in symptoms and quality of life with low FODMAP dietPederson et al70
Non-blinded randomised placebo-controlledPatients with IBS (Rome III)e-health-delivered low FODMAP diet (n=42)Probiotic+habitual diet (n=41); and habitual diet alone (n=40)6 weeksLow 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.