What question did this study set out to answer?

This research tests the effectiveness of a microbiota-targeted Mediterranean diet in improving clinical and inflammatory outcomes in early Crohn’s disease.

January 23, 2026

P0905The Mediterranean diet improves clinical and inflammatory outcomes in patients with early Crohn’s Disease: Results from the IBDMED randomized controlled trial

Key Points

This research tests the effectiveness of a microbiota-targeted Mediterranean diet in improving clinical and inflammatory outcomes in early Crohn’s disease.
Randomized controlled trial comparing IBDMED program with standard dietary counseling
Participants received personalized dietary consultations and support via mobile app
Assessment of clinical outcomes, quality of life, and inflammatory markers before and after 8 weeks
Significant improvement in the Harvey-Bradshaw Index in the IBDMED group (p = 0.02)
Clinical remission achieved in 80% of patients with active disease in the IBDMED group vs. 40% in controls
Fecal calprotectin decreased significantly in the IBDMED group (p = 0.0019)

Abstract

Abstract Background The Mediterranean diet (MED) is increasingly recommended for patients with inflammatory bowel disease (IBD), yet evidence on its clinical impact and its effect on inflammatory markers remains limited. This study aimed to test the feasibility and effectiveness of a microbiota-targeted MED-based nutritional education program (IBDMED), in patients with early Crohn’s disease (CD) in Israel (ISR) and India (IND). Methods Patients with early mild-to-moderate CD, and inflammatory phenotype (B1), were randomized to either the IBDMED program or a local standard-of-care dietary counseling (control). The IBDMED program included personalized dietary consultations with dietitians, a mobile application providing MED guidance, online support, and the use of wearables to monitor lifestyle parameters. Clinical outcomes Harvey-Bradshaw Index (HBI), quality of life (QoL) measures (s-IBDQ, IBD-Control), fecal calprotectin (FC), and changes in microbiome composition, were assessed before and after the 8-week intervention (NCT05536544). Results A total of 78 patients completed the 8-week intervention (ISR = 42; IND = 36). The median age was 34 years IQR 25-42 and median BMI was 23.2 kg/m2 IQR 20.5-26.7. Overall, HBI improved from 2 IQR 1-4.5 to 1 1-3.5 in the IBDMED group (p = 0.02), with greater improvement in the ISR cohort from 4 3-7 to 2 0-4 (p = 0.004), compared with no significant changes in controls. Among patients with active disease (baseline HBI≥5), clinical remission was achieved in 8/10 (80%) in the IBDMED group compared with 4/10 (40%) in controls. Baseline QoL scores were higher in the IND cohort and improved overall in both ISR and IND, with significant improvement in the s-IBDQ in the IBDMED group and in the IBD-Control in both groups (p 0.05). FC significantly decreased in the IBDMED group from 221 126-400 to 136 27-266 µg/g (p = 0.0019), while remaining comparable in controls. FC response, defined as a 50% reduction in patients with baseline levels 100 µg/g, was observed in 15/30 (50%) in the IBDMED group and 11/26 (42.3%) in controls. Reduction in FC was associated with increased IBDMED adherence score (p 0.05). Preliminary microbial analysis revealed that clinical improvement was associated with increased microbial diversity, driven by increased relative abundances of butyrate producers. Conclusion The IBDMED program is feasible and leads to clinical, QoL and inflammatory improvements in patients with early CD. These may be mediated by positive microbial changes and highlight the potential role of a microbiota-targeted and culturally adapted MED programs across different geographic populations, in modulating inflammation in patients with CD. Conflict of interest: Dr. Godny, Lihi: Grant: Helmsley Charitable Trust Raghunathan, Nalini: None Reshef, Leah: No conflict of interest Elial-Fatal, Sarine: None Shakhman, Shelly: No conflicts Fathima, Sana: None Pfeffer-Gik, Tamar: Altman Health Janssen Strauss group Kutukov, Lena: No conflict of interest Friedenberg, Adi: No conflict of interest Pauker, Maor: No conflict of interest Rabinowitz, Keren: No conflict of interest Barkan, Revital: Grant: Research grants from Pfizer and Abbvie Sharar Fischler, Tali: No conflict of interest Lichtenstein, Lev: No conflict of interest Mor, Michal Zehava: No conflict of interest Sehayek-Shabat, Vered: No conflict of interest Peleg, Idit: No conflict of interest Tamir-Degabli, Natalie: No conflict of interest Glusman-Bendersky, Ahinoam: No conflict of interest Kornowski Cohen, Maya: No conflict of interest Reiss Mintz, Hilla: No conflict of interest Odeh, Safwat: No conflict of interest Mekala, Dhanush: No conflict of interest Gunala, Nikhil: No conflict of interest Kalpakam, Kripa: No conflict of interest Thakur, Manisha: No conflict of interest P, Ambica: No conflict of interest Ollech, Jacob: No conflict of interest Snir, Yifat: No conflict of interest Broytman, Yelena: No conflict of interest Avni Biron, Irit: No conflict of interest Banai Eran, Hagar: No conflict of interest Yanai, Henit: Grant: Pfizer, ISF Personal Fees: AbbVie, Janssen, Pfizer, Takeda, Bristol Myers Squibb, and Elly Lilli. Gophna, Uri: No conflict of interest Banerjee, Rupa: RB has received grants/research support from Asian Healthcare Foundation, and the Leona M and Harry B Helmsley Charitable Trust Advisory board fees from Abbott, AstraZeneca, Abbvie, Cadila, Cipla, Dr Reddy Labs, Eli Lilly, Emcure, Ferring Pharma, Hetero Drugs, Janssen, MSN Labs, Mankind Pharma, Menarini, Micro Labs, Pfizer, Sun Pharmaceuticals, Takeda Pharmaceuticals, Torrent, Waterley, and Zydus. Dotan, Iris: Grant: The Leona M. and Harry B. Helmsley Charitable Trust, Altman Research, Pfizer, BMS Personal Fees: Pfizer, Falk, Ferring, Abbvie, Janssen, Celltrion, Takeda, Celgene/BMS, Gilead, Galapagos, Materia Prima, Sandoz, Sublimity, Sangamo, Spyre, Eli-Lilly, Harp Diagnostics, Gutreat, Astra Zeneca

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