P323 The Crohn's Disease Exclusion Diet (CDED) for pouch inflammation: an interventional pilot study
Fliss Isakov, N.(1);Kornblum, J.(1);Zemel, M.(2);Hirsch, A.(1);Maharshak, N.(1);
(1)Tel Aviv Sourasky Medical Center, Department of Gastroenterology and Liver Diseases- Sackler Faculty of Medicine, Tel Aviv, Israel;(2)Tel Aviv Sourasky Medical Center, Surgery division, Tel Aviv, Israel;
Background
Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical treatment of choice for patients with UC. Unfortunately, pouchitis is a common condition, reported in up to 72% of pouch patients. Pouchitis pathogenesis is not entirely clear and has similarities to that of Crohn's disease (CD), given the de-novo inflammation of the small intestine, the microbial dysbiosis and the occurrence of a penetrating phenotype. The Crohn's Disease Exclusion Diet (CDED) has demonstrated its efficacy in improving clinical and biochemical parameters of intestinal inflammation in CD. Therefore, we aimed to examine whether the CDED may be effective for the treatment of active pouchitis.
Methods
A non-controlled, open-label, interventional pilot trial. Active pouchitis patients were recruited at the comprehensive pouch clinic of the Tel Aviv Medical Center (TLVMC), a tertiary center. Patients were treated with the CDED (phases 1-3) for 24 weeks, underwent 5 clinic visits (weeks 0, 3, 6, 12 and 24) which included physician assessment and monitoring [clinical pouch disease activity index (cPDAI) sub score evaluation], dietary evaluation and guidance, inflammatory biomarkers evaluation, and collection of biologic samples. Patients underwent three pouchoscopy procedures (baseline, end of phase 2 and end of phase 3) for assessment of endoscopic and histologic disease activity. The primary endpoint of the study was week-6 clinical remission (cPDAI subscore≥2).
Results
Fifteen patients (mean age 42.6±11.2, 3 males, mean pouch age 14.7±10.7 years) with pouchitis were recruited (Crohn's like disease of the pouch, n=5; chronic pouchitis, n=4; acute pouchitis, n=3; recurrent acute pouchitis, n=3). Nine patients completed the study protocol and were evaluated throughout 24 weeks, while six patients were withdrawn: four due to exacerbation requiring antibiotics, and two due to bowel obstruction. No other adverse events were noted. Clinical remission was achieved by 66.7% of the study population at week 6 by per-protocol analysis, and was maintained by 60.0% at week 12. Modified PDAI (mPDAI) decreased at week 12 compared to baseline (8.0 vs. 5.0, P=0.027), with an improvement in the median number of defecations per day (24h) (12.5 vs. 7.0, P=0.003), and night (2.5 vs. 1.0, P=0.018). CRP and fecal calprotectin decreased compared to baseline (11.1±5.2 vs 6.0±4.0, P=0.007, and 697±680 vs 497±483, P=0.607). Among patients who achieved clinical remission at week 6, 80% maintained remission at week 12 (P=0.025).
Conclusion
This pilot study demonstrates that CDED is a beneficial and safe therapeutic dietary intervention for pouchitis. Larger controlled trials should be performed in this population.