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Long-term microbiome and clinical effects of a microbiome-guided personalized diet versus low-FODMAP diet in irritable bowel syndrome: A 12-month follow-up randomized controlled trial.

Varol Tunali·Naciye Çiğdem Arslan·Gözde Derviş Haki̇m·Aycan Gündoğdu·Beyza Hilal Ermi̇ş·Mehmet Hora·Özkan Ufuk Nalbantoğlu
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Abstract

Dietary therapy is central to irritable bowel syndrome (IBS) management, yet the long-term durability of the low-FODMAP diet (LFD), and of microbiome-guided personalization, remains unclear. We assessed the long-term clinical and gut-microbiome effects of a microbiome-guided personalized diet (PD) compared with a standard LFD in adults meeting Rome IV criteria for IBS. In this multicenter, open-label randomized controlled trial with blinded outcome assessment, participants who completed a 6-week dietary intervention (PD or LFD) were followed at 6 and 12 months without further dietary intervention. Outcomes included the IBS Severity Scoring System (IBS-SSS), IBS Quality of Life (IBS-QOL), and the Hospital Anxiety and Depression Scale (HADS); gut microbiota were profiled by 16S rRNA sequencing. Longitudinal changes were evaluated using linear mixed-effects models, responder analyses, PERMANOVA, and PERMDISP. Both diets reduced IBS-SSS at 6 weeks. PD maintained symptom improvement at 6 and 12 months (-82.0 and -78.3 points from baseline), whereas LFD benefits regressed by 12 months (+29.3 points; between-group p&#x2009;=&#x2009;0.001). At 12 months, IBS-SSS responder rates were higher with PD than LFD (62.5% vs 34.5%; absolute risk difference&#x2009;+28.0%, 95% CI 4.2-47.7; Fisher p&#x2009;=&#x2009;0.029), and IBS-QOL, HADS-anxiety, and HADS-depression showed more favourable trajectories with PD. PD was associated with sustained Shannon alpha-diversity gains (+0.488 at 6 weeks;&#x2009;+0.205 at 12 months; both p&#x2009;<&#x2009;0.01). A modest between-group beta-diversity difference at 6 months (R2&#x2009;=&#x2009;0.035; p&#x2009;=&#x2009;0.011) was not significant at 12 months. This hypothesis-generating follow-up suggests more durable benefit with PD; larger trials powered for long-term clinical and microbiome outcomes are warranted.

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HumansIrritable Bowel SyndromeFemaleAdultMaleFollow-Up StudiesFODMAP DietMiddle AgedGastrointestinal MicrobiomeQuality of LifeTreatment OutcomeBacteriaRNA, Ribosomal, 16SPrecision MedicineFeces16S rRNA sequencingIrritable bowel syndromealpha diversityartificial intelligencedietary interventionlow-FODMAP dietmicrobiomepersonalized dietprecision nutritionrandomized trialJournal ArticleRandomized Controlled TrialMulticenter Study

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Varol Tunali, Naciye &#xc7;i&#x11f;dem Arslan, G&#xf6;zde Dervi&#x15f; Haki&#x307;m, Aycan G&#xfc;ndo&#x11f;du, Beyza Hilal Ermi&#x307;&#x15f;, Mehmet Hora, &#xd6;zkan Ufuk Nalbanto&#x11f;lu. 2026-08-20. Long-term microbiome and clinical effects of a microbiome-guided personalized diet versus low-FODMAP diet in irritable bowel syndrome: A 12-month follow-up randomized controlled trial.. https://doi.org/10.1080/19490976.2026.2719125

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Journal Article; Randomized Controlled Trial; Multicenter Study resource16S rRNA sequencing subjectAdult subjectArtificial Intelligence subjectBacteria subjectFODMAP Diet subjectFeces subjectFemale subjectFollow-Up Studies subjectGastrointestinal Microbiome subjectHumans subjectIrritable Bowel Syndrome subjectJournal Article subjectMale subjectMiddle Aged subjectMulticenter Study subject

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