Low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols dietversustraditional dietary advice for functional dyspepsia: a randomized controlled trial

Abstract

Background and Aim Prospective trials evaluating efficacy of specific diet restriction in functional dyspepsia (FD) are scarce. We aimed to assess efficacy of low fermentable oligosaccharides, disaccharides, monosaccharides, and polyols (FODMAP) diet in FD, compared with traditional dietary advice (TDA). Methods In this prospective, single‐blind trial, patients with FD (Rome IV) were randomized into low FODMAP diet (LFD) and TDA groups, for 4 weeks (phase I). In phase II (4–12 weeks), LFD group was advised systematic re‐introduction of FODMAPs. Symptom severity and quality of life were assessed using “Short‐Form Nepean Dyspepsia Index (SF‐NDI).” Primary outcome was symptomatic response (symptom score reduction of ≥ 50%), at 4 weeks. Study was registered with CTRI (2019/06/019852). Results Of 184 patients screened, 105 were randomized to LFD (n = 54) and TDA (n = 51) groups. At 4 weeks, both groups showed significant reduction in SF‐NDI symptom scores compared with baseline, with no significant difference in inter‐group response rates [LFD: 66.7% (36/54); TDA: 56.9% (29/51); P = 0.32]. On sub‐group analysis, patients with postprandial distress syndrome or bloating had significantly better symptomatic response with LFD (P = 0.04). SF‐NDI quality of life scores improved significantly in both groups. On multivariate analysis, factors predicting response to LFD were bloating and male gender. Incidences of adverse events (minor) were similar in both groups. Conclusions In patients with FD, LFD and TDA lead to significant symptomatic and quality of life improvement. Patients with postprandial distress syndrome or bloating respond significantly better to LFD. Therefore, dietary advice for FD should be individualized according to FD subtype.

Exclusion Diets in Functional Dyspepsia

“…Additionally, in a prospective, single-blind trial, 105 patients diagnosed with FD by Rome IV criteria were randomized into two groups low FODMAP diet ( n = 54) and traditional diet advice groups ( n = 51), for four weeks [ 26 ]. In a second phase, for the next eight weeks, the LFD group were re-exposed to FODMAPs.…”

“…Interestingly, patients with post-prandial distress syndrome or bloating had a higher response rate to low FODMAP diet ( p = 0.04). Both interventions improved SF-NDI quality of life scores and multivariate analysis revealed that bloating and male gender were factors predicting response to LFD [ 26 ].…”

“…The quality assessment of the included studies is outlined in Supplementary File (Tables S1–S4) . Overall, six studies were rated as “Good” [ 24 , 25 , 26 , 35 , 36 , 37 ] and two studies were regarded as “Fair” [ 23 , 27 ] quality. All studies considered had adequate statistical methods, correctly assessing outcomes using valid and reliable measures.…”

“…All studies considered had adequate statistical methods, correctly assessing outcomes using valid and reliable measures. When it comes to controlled intervention studies, all four of them had proper randomization of participants, with patients and providers being blinded to the participants’ group assignment [ 23 , 26 , 35 , 36 ].…”

Evidence-Based and Emerging Dietary Approaches to Upper Disorders of Gut–Brain Interaction

“…A beneficial effect of a low FODMAP diet compared with standard dietary advice was reported in a cohort of 59 patients with FD, but with 81% having coexisting IBS ( 67 ). Goyal et al ( 68 ) compared the effect of a 4-week low FODMAP diet to traditional dietary advice in a group of 105 patients with Rome IV FD where those with overlapping IBS and other dietary-related conditions (e.g., a history of lactose/fructose intolerance and patients already on restricted diet) were excluded. Symptoms improved in 67% after a low FODMAP diet compared with 57% after traditional dietary advice, mainly in the PDS subgroup and without significant difference between diets.…”