Clinical Trial: A Mediterranean Low-FODMAP Diet Alleviates Symptoms of Non-Constipation IBS—Randomized Controlled Study and Volatomics Analysis
Arezina Kasti, Konstantinos Katsas, Dimitris Pavlidis, Emmanouil Stylianakis, Konstantinos Petsis, Sophia Lambrinou, Maroulla D. Nikolaki, Ioannis S. Papanikolaou, Erifili Hatziagelaki, Konstantinos Papadimitriou, John Kapolos, Jane G. Muir, Κonstantinos Τriantafyllou
Abstract
Background: Approximately 20% of patients with irritable bowel syndrome (IBS) link symptoms to food intake; a low-FODMAP diet is effective in managing these symptoms. Aims: To evaluate the effectiveness of the Mediterranean version of the low-FODMAP Diet (MED–LFD) compared to NICE guidelines for IBS and to assess changes in stool volatile compound levels. Methods: 108 patients with Rome IV IBS without constipation were randomized into the MED–LFD or NICE group. Primary endpoints included changes in symptom severity and responder rate (reduction of >50 IBS-SSS points) after intervention and at 6 months. Secondary endpoints assessed quality of life, symptom burden, adequate relief, anxiety/depression levels, and adherence. Volatile compound levels were measured using Gas Chromatography/Mass Spectrometry. Results: At both time points, the MED–LFD group showed a significantly greater improvement in symptom severity (159 ± 80 vs. 253 ± 94 and 168 ± 117 vs. 245 ± 98), responder rates (84.6% vs. 60.8% and 79.1% vs. 52.3%), and adherence (75% vs. 41% and 45% vs. 7%). Similar results were observed for all secondary endpoints, with no serious adverse events reported. The MED–LFD intervention was the strongest independent predictor of being a responder at the first (OR = 6.66; 95%CI = 1.46, 30.4) and second follow-up (OR = 4.85; 95%CI = 1.31, 17.96). Short and branched-chain fatty acids were significantly reduced at both follow-ups. Conclusions: The MED–LFD is superior to NICE recommendations in managing non-constipated IBS symptoms and quality of life. It remains to be proven that reduced volatile compound levels might be an objective marker of response to dietary interventions. ClinicalTrials.gov ID: NCT03997708.