Introduction
The low-FODMAP diet (LFD) is the most well-documented diet intervention for significantly improving irritable bowel syndrome (IBS) symptoms. The Mediterranean diet (MED), with plant-based foods, olive oil, fruits, herbs, wine, and lean proteins, has antioxidant properties that might ameliorate the low-grade inflammation characterizing the syndrome. The efficacy of the two diets combined in IBS is unknown.
Aims & Methods
Our primary aim was to examine the efficacy of combining LFD with MED diet components (MED-LFD) compared to the nutritional recommendations of the British National Institute for Health and Care Excellence (NICE) for managing non-constipation IBS.
Single-center, randomized, parallel groups design, single-masked, controlled study with six months of follow-up. We enrolled patients fulfilling Rome IV criteria with Bristol Stool Form Scale 3-7, IBS-SSS > 175, normal TSH, negative tTg-IgA/IgG, without either chronic systemic disorder or probiotic and/or antibiotic administration within a month before enrolment. Patients were randomized to either MED-LFD that included swapping high FODMAP for low FODMAP alternatives (1st phase), gradual introduction of foods rich in FODMAPs to test tolerance (2nd phase), and individualized diet based on personal tolerance (3rd phase) or a diet according to their energy needs adjusted to NICE recommendation for IBS. Patients were evaluated at baseline and follow-ups (1stFU: 4 weeks after initiation of intervention for NICE and at the end of phase 2 for MED-LFD, 2ndFU: at six 6 months) with: IBS-SSS (intervention responder: drop of >50 points), IBS-QOL, SF-12, modified for lower GI symptoms burden GSRS, and HADS.
Results
From July 2019 to April 2023, 108 patients (77.8% females, 40±11 yrs) were randomized (1:1) to MED-LFD or NICE diet groups. 92 (85.2%) patients completed the study. Primary endpoints: 1. Responders' rate was significantly higher in the MED-LFD group in the ITT and PP analysis at the 1st (81.5% vs. 57.4%, p=0.007 and 84.6% vs. 60.8%, p=0.007) and 2nd (68.5% vs. 40.7%, p=0.004 and 80.4% vs. 51.2%, p=0.004) FUs, respectively. 2. At both FUs, the MED-LFD group showed significantly greater improvement in symptom severity (IBS-SSS: 159±80 vs. 253±94 and 168±117 vs. 245±98). For all secondary endpoints (Table 1), patients in the MED-LFD group showed significantly higher improvement than the NICE group at each FU. Adherence rate was significantly higher in the MED-LFD group at both FUs (75% vs. 41% and 45% vs. 7%). No patient discontinued the intervention due to an adverse event. Eighteen (10 and eight in the MED-LFD and NICE groups, respectively) patients reported the use of rescue medication 26 times (12 and 14 in MED-LFD and NICE groups, respectively) during the intervention, including paracetamol (n=10), loperamide (n=14) and a combination of the two medications in two cases.
Table 1. Secondary endpoints: * denotes significant difference over baseline score at the different time points; $ denotes significant difference over comparator score at the FU.
| Score, mean (sd) | Baseline MED-LFD | Baseline NICE | 1st FU MED-LFD | 1st FU NICE | 2nd FU MED-LFD | 2nd FU NICE |
| GSRS (LGI) | 4.02 (0.94) | 3.95 (0.82) | 2.35 (0.82)*, $ | 3.3 (1.2)* | 2.53 (1.18)*, $ | 3.44 (1.39)* |
| SF-12 total | 40.2 (7.9) | 39.3 (7.0) | 46.5 (6.9)*, $ | 43.3 (7.8)* | 48.9 (8.0)*, $ | 42.9 (8.3) |
| IBS-QoL total | 47.5 (20.6) | 49.4 (21.5) | 71.7 (16.8)*, $ | 58.3 (22.4)* | 73.7 (21.1)*, $ | 61 (21.5)* |
| HADS anxiety | 8.94 (4.64) | 9.45 (4.67) | 6.77 (4.11)*, $ | 8.62 (4.96) | 5.81 (4.51)*, $ | 8.39 (4.75) |
| HADS depression | 8.10 (4.68) | 8.59 (3.82) | 5.22 (3.97)*, $ | 7.41 (3.95)* | 4.79 (4.13)*, $ | 7.66 (4.29) |
Conclusion
Low-FODMAP diet combined with Mediterranean diet components is superior to the NICE nutritional recommendations for amelioration of IBS symptoms and improvement of quality of life of non-constipated IBS patients. The results are sustainable for six months
References
ClinicalTrials.gov identifier: NCT03997708