RESUMO
BACKGROUND: A diet low in fermentable oligo-saccharides, di-saccharides, mono-saccharides and polyols (low FODMAP diet) is complex and clinical effectiveness is achieved with dietitian-led education, although dietitian availability in clinical practice varies. This study aimed to assess the feasibility of undertaking a trial to investigate the clinical and cost-effectiveness of different education delivery methods of the low FODMAP diet in patients with disorders of gut-brain interaction (DGBI). METHODS: In this feasibility randomized controlled trial, patients with DGBI requiring the low FODMAP diet were randomized to receive one of the following education delivery methods: booklet, app, or dietitian. Recruitment and retention rates, acceptability, symptoms, stool output, quality of life, and dietary intake were assessed. KEY RESULTS: Fifty-one patients were randomized with a recruitment rate of 2.4 patients/month and retention of 48 of 51 (94%). Nobody in the booklet group strongly agreed that this education delivery method enabled them to self-manage symptoms without further support, compared to 7 of 14 (50%) in the dietitian group (p = 0.013). More patients reported adequate relief of symptoms in the dietitian group (12, 80%) compared with the booklet group (7, 39%; p = 0.026), but not when compared to the app group (10, 63%, p > 0.05). There was a greater decrease in the IBS-SSS score in the dietitian group (mean -153, SD 90) compared with the booklet group (mean -90, SD 56; p = 0.043), but not when compared with the app group (mean -120, SD 62; p = 0.595). CONCLUSIONS & INFERENCES: Booklets were the least acceptable education delivery methods. Dietitian-led consultations led to high levels of clinical effectiveness, followed by the app, while the dietitian was superior to booklets alone. However, an adequately powered clinical trial is needed to confirm clinical effectiveness of these education delivery methods.
