P323 The Crohn’s Disease Exclusion Diet (CDED) for pouch inflammation: an interventional pilot study

Abstract 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 Nine patients completed the study protocol and were evaluated throughout, 24 weeks, while six patients were withdrawn: four due to exacerbation requiring antibiotics, and two due to bowel obstruction.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. </jats:sec

P559 Cannabis Improves Sleep Quality in Patients with Inflammatory Bowel Diseases in a Prospective Observational Study

Abstract Background Poor sleep is associated with adverse health consequences and was shown to be associated with subclinically active inflammatory bowel diseases (IBD). Altered sleep patterns in IBD patients were associated with frequent disease flares and lower quality of life. The aim of this study was to assess the effect of cannabis use on sleep quality in IBD patients. Methods We conducted a prospective observational cohort study enrolling 160 IBD patients who were prescribed medical cannabis. Patients who changed medication during the trial, reported use of cannabis 3 months before the trial, or failed to follow up were excluded from the analysis. Patients filled questionnaires at baseline and after 3 and 6 months of therapy. Sleep quality was measured using the Pittsburgh Sleep Quality Index (PSQI). Results A total of 91 patients were included, of these 62.6(57%) were males and 74(81.3%) were diagnosed with Crohn’s disease (CD). Their median age was 36.71 years (range 20.1–73.2) and their median disease duration was 9 years (range 0.5–55.1). The median cannabis dose prescribed was 20 grams (range 10–40). Patients reported an improved sleep quality with decreased mean PSQI score after 3 months (7.1±3.85 vs 7.8±3.9, p=0.004) and further improvement after 6 months (6.9±3.7 vs 7.8±3.9, p=0.006) of cannabis therapy, compared to baseline. Cannabis therapy was safe with no severe adverse or side effects. Conclusion Cannabis use is an effective and safe intervention to improve sleep quality in IBD patients. The impact of cannabis on the disease activity and its association with sleep improvement in these patients should be further explored. </jats:sec

P442 Serum vedolizumab trough levels are associated with remission rate but not with extra-intestinal manifestations in IBD patients

Abstract Background The correlation between vedolizumab trough levels and inflammatory bowel diseases (IBD) remission rates has not yet been fully defined. We aimed to evaluate the association between vedolizumab serum trough levels and disease clinical and extra-intestinal manifestations (EIMs) and biomarker activity in IBD patients. Methods Forty-six patients (31 ulcerative colitis, 15 Crohn’s disease) who started vedolizumab therapy were retrospectively followed. Clinical and laboratory data were collected before treatment, during induction and maintenance until week 52 from initiation. Documentation of EIMs included peripheral and axial arthropathy, cutaneous and ocular manifestations and perianal disease. Clinical remission was defined as a Harvey-Bradshaw Index (HBI)&amp;lt;5 or a Simple Clinical Colitis Activity Index (SCCAI)&amp;lt;3. Biomarker normalization was defined as C-reactive protein level&amp;lt;5 mg/L and fecal calprotectin level&amp;lt;250 µg/g. Two-sample t-tests were used to find correlations between drug levels and disease activity. Results Higher week-2 trough serum vedolizumab levels were associated with week 14 clinical remission compared to patients with an active disease (30.55±2.22 µg/ml vs 22.28±3.57µg/ml, p=0.05) and with weeks-14 and -30 biomarker normalization (33.77±2.98 µg/ml vs 23.6±3.19 µg/ml, p=0.05 and 30.33±1.95 µg/ml vs 19.66±6.83 µg/ml, p=0.05, respectively). Week-6 vedolizumab levels were associated with week-30 clinical remission (30.52±3.48 µg/ml vs 15.35±4.94 µg/ml, p=0.03) and biomarker normalization (28.44±2.36 µg/ml vs 15.76±4.87µg/ml, p=0.02), and week 14 vedolizumab levels were associated week 30 biomarker normalization (14.81±1.64 µg/ml vs 6.23±2.25 µg/ml, p=0.03). Throughout the follow-up period, 24% of patients presented with EIMs (n=11). No association was found between vedolizumab levels and endoscopic outcomes or EIMs activity. Conclusion Trough serum vedolizumab levels at induction is associated with remission induction and maintenance but not with EIMs improvement. Assessment of early vedolizumab trough levels may be considered for prediction of response to therapy. </jats:sec

P811 A watchful approach for newly diagnosed Crohn’s disease patients with an inflammatory phenotype

Abstract Background Early treat-to-target approach in Crohn’s disease (CD) patients is recommended to avoid complications. However, CD may not progress in all patients, despite lack of treatment or 5-ASA medications use, exposing this group of patients to unnecessary side effects if treated according to guidelines. We aimed to examine whether newly diagnosed CD patients with an inflammatory phenotype can benefit from a watchful approach. Methods This was a retrospective cohort study following CD patients at a tertiary centre, who were diagnosed between 2010 and 2015 and were followed for at least 1 year. Only patients with an inflammatory phenotype (Montreal classification B1) were included. Epidemiologic, clinical and endoscopic data was retrieved from medical records. A watchful approach was defined as maintenance therapy with 5-ASA medication only or no treatment at all during first year of diagnosis or further. Disease complications were defined as surgery or change in disease phenotype. Results Thirty-seven patients, (35.1% males at a mean age of 41.4 ± 19.6 years) were included in the study. During the follow-up period of 54.9 ± 28.7 months, 31 patients (86.0%) did not develop disease complications. The patients were characterised by females predominance (83.3% vs. 25.8%, p = 0.007), less smokers (25.8% vs. 83.3%, p = 0.006), earlier diagnosis from symptom onset (9.6 ± 15.6 months vs. 49.8 ± 57.0 months, p = 0.001) and prednisone therapy at diagnosis (87.1% vs. 50.0%, p = 0.032), compared with the patients that developed complications. There was no difference in clinical disease severity (HBI score 2.9 ± 1.5 vs. 3.1 ± 0.9, p = 0.721) or endoscopic activity (SES-CD score 6.3 ± 4.8 vs. 5.0 ± 4.8, p = 0.528) at diagnosis. Only 22.6% (7/31) of the patients were eventually treated with thiopurines or biologics for disease exacerbation. Conclusion A watchful approach of newly diagnosed CD patients with an inflammatory phenotype can be considered, especially in non-smoking women. This sub-group should be further characterised. </jats:sec

P788 Gender differences in consumption of processed and ultra-processed foods in Crohn’s disease patients

Abstract Background Consumption of processed foods is thought to be associated with Crohn’s disease (CD) pathogenesis. In Israel, CD demonstrates higher prevalence rate among men. Our aim was to examine gender differences among CD patients in the consumption of processed foods. Methods A post hoc analysis of a prospective validation study of a novel processed food questionnaire (PFQ) was performed in adult CD patients followed at a tertiary center in Israel. The PFQ categorises food items according to the level of processing as unprocessed or minimally processed, processed and ultra-processed foods. Demographic and clinical data were collected. Linear regression, ANOVA, t-test were performed looking at the association between disease characteristics, age, education, gender and consumption of processed foods. Results Sixty patients (33 men, 27 women) were included in the analysis. Mean age of participants was 29.4 ± 8.6 for men and 31.7 ± 10.2 for women. Men consumed on average more portions of processed foods per day than women (3.09 ± 2.31 vs. 1.98 ± 1.32, p = 0.023, respectively). Similar association was found for ultra-processed foods consumption, where men consumed 1.63 ± 0.75 more portions per day than women (5.77 ± 2.90 vs. 4.14 ± 2.87, p = 0.034, respectively). Disease characteristics (duration, behaviour, and activity), age and education levels were not associated with consumption of processed foods. Conclusion Men with CD consumed significantly more processed and ultra-processed foods compared with women, emphasising a need for dietary intervention in men if these findings are consistent in larger studies. </jats:sec

P839 Clinical activity in inflammatory bowel diseases is associated with consumption of processed foods

Abstract Background Western diet and its food components have been suggested to influence inflammatory bowel diseases (IBD) clinical course. However, the association of dietary processing factors and disease activity is uncertain. We aimed to evaluate whether intake of foods with varying processing levels is associated with disease activity in IBD patients. Methods A cross-sectional study of adult patients with IBD was performed at a tertiary center between August 2019 to June 2022, by collecting clinical and dietary data from consecutive patients who signed an informed consent form. Clinical activity was defined using HBI (Crohn's disease) and SCCAI (ulcerative colitis). Dietary intake was assessed using a dedicated validated processed food questionnaire (PFQ) that categorizes dietary intake into three groups of processed food levels: unprocessed or minimally processed, processed, and ultra-processed. Adjusted odds ratios for disease activity were determined using a multivariate logistic regression. Results A total of 242 IBD patients (62.8% Crohn’s disease patients) were enrolled, of whom 73.1% were in clinical remission. Comparing the higher tertile to the lowest tertile of foods consumption - unprocessed foods (OR 0.29, 95% CI 0.13-0.65) and processed foods (OR 0.40, 95% CI 0.19-0.82) were negatively associated with disease activity, while high consumption of ultra-processed foods was positively associated with active disease (OR 2.24, 95% CI 1.05-4.77). All ultra-processed food subgroups were positively associated with higher odds of active disease. Conclusion Higher intake of unprocessed or minimally processed foods was associated with lower odds of clinically active IBD, while higher ultra-processed foods intake was associated with higher odds of active disease. Further studies are needed to evaluate the impact of different levels of food processing on disease activity. </jats:sec

P473 Real world experience with the Crohn’s Disease Exclusion Diet (CDED) in a tertiary IBD clinic

Abstract Background The Crohn’s Disease Exclusion Diet (CDED) is a whole-food diet designed to reduce exposure to dietary components, hypothesized to negatively affect the microbiome, intestinal barrier, and immune response. In a clinical study in adults with mild-moderate CD (&amp;lt;5 years duration), an inflammatory phenotype involving the terminal ileum, it induced clinical, biochemical and endoscopic disease remission. We aimed to describe our real-world experience with the CDED, in a clinically diverse CD population. Methods A retrospective cohort study of CD patients prescribed with the CDED, between 1.2018 and 11.21. Patients’ medical background, medical therapy, nutritional status and clinical disease activity as well as adherence and clinical outcomes were documented from patients’ medical files. Results The CDED was recommended to 218 CD patients. Of these, 62 were excluded from the analysis due to lack of medical information (n=11), prior personal experience with the CDED (n=23), patient’s refusal (n=24), and stoma patients (n=4). The CDED was initiated in 155 patients (age 37.7±16.3, 66% men, disease duration 7.8±9.6), 35.3% had colonic/ileo-colonic disease, 23.7% and 25% had a stricturing and penetrating disease respectively, 27.5% had a history of intestinal resection, 19.9% had extra-intestinal involvement, and 7.7% had a severe endoscopic disease at diet initiation. Indications for therapy included patient’s will (44.7%), adjunctive therapy (23.7%), bridge with biologic induction (20.4%), rescue therapy (3.9%), exhaustion/contraindication of other advanced therapy options (1.4%), de-escalation of biologics (0.7%), preparation for surgery (0.7%), and others (3.9%). Upon initiation, 67.3% (n=105) had an active disease [Harvey Bradshaw index (HBI) ≥5 / Calprotectin ≥250 g/l] and 32.7% were in remission. Physician and dietician follow-up at the end of phase 1 was documented in 89 (57.4%) and 74 (47.7%) of patients with an active disease (mean follow-up period 14.6±9.3 weeks). Fifty-eight percent of patients with dietary follow-up (n=43) were fairly-fully compliant to the CDED. Clinical response (drop in HBI&amp;gt;2 points) and remission (HBI&amp;lt;5) at the end of phase 1, were achieved by 58.9% (n=62) and 57.5% (n=60) of patients who were treated for an active disease (n=105). Clinical remission rate at the end of phase 1 was lower among patients with higher baseline HBI score (P for trend=0.028), lower dietary adherence (P for trend&amp;lt;0.001) and a surgical history (P=0.033). Conclusion The CDED may have efficacy across different clinical scenarios. Adherence is reasonable, and is associated with higher remission rates among patients treated for an active disease. </jats:sec

P511 Disease-specific risk factors for malnutrition development in IBD

Abstract Background Patients with inflammatory bowel diseases (IBD) are at risk of malnutrition, which is associated with considerable disease related complications. Most available screening tools for malnutrition risk such as the malnutrition universal screening tool (MUST), do not incorporate malnutrition-promoting characteristics of IBDs. Therefore, we aimed to detect disease-specific risk factors for malnutrition development in IBD, which may be incorporated in future malnutrition screening tools. Methods A retrospective case-control study, in which detailed information regarding IBD patients treated at the IBD clinic of the Tel-Aviv Medical Center between 2010–2020 was collected. Cases were patients who developed malnutrition between clinic visits (defined as BMI≤18.5/ weight loss ≥5% of body weight during 3 months/≥10% of body weight during 6 months) and controls were those who maintained a normal nutritional status. Cases and controls were matched by age, gender, disease and disease duration. Data was collected from medical files included reported medical history, clinical manifestations of disease, disease activity, and nutritional status including MUST evaluation during clinic visits. The association between the clinical data and malnutrition development was evaluated using a logistic regression model, with adjustment for MUST components: weight loss of ≥5% of body weight and multiple (≥2) reasons for inadequate nutritional intake. Results We collected data from 118 IBD patient (cases, n=59 and controls n= 59, Crohn’s disease n=76, ulcerative colitis n=28, pouchitis patients n=14). All patients were at normal nutritional status at baseline. Patients were followed for a period of 6.2±3.0 months during which, cases lost 5.3±2.3 kg (10.4±4.8 % body weight) and controls gained 0.2±2.3 kg )0.2±3.5 % body weight) (p&amp;lt;0.001). MUST screening misclassified 34% of cases as low risk for malnutrition. Development of malnutrition was positively associated with baseline endoscopic disease activity [Odds ratio (OR)=6.06, 95% Confidence interval (CI) 1.91–19.18], repeated physician/nurse clinic visits ≥4/year (OR=5.26, 1.20–22.98), and negatively associated with advanced therapy (biologics and small molecules) (OR=0.151, 0.03–0.70), and BMI at baseline (OR=0.24, 0.13–0.44). The fit of this model was evaluated by an area under the curve of AUC=0.961 CI 0.93–0.99, p&amp;lt;0.001. Conclusion Current tools for prediction of malnutrition among IBD patients are not sensitive enough. Parameters, such as increased disease activity should prompt nutritional assessment among patients to prevent mal-nutrition. The importance of these findings should be evaluated in prospective studies. </jats:sec

DOP68 Assessment of patients’ understanding of Inflammatory Bowel Diseases (IBD): Development and validation of a questionnaire (U-IBDQ)

Abstract Background Education of inflammatory bowel disease (IBD) patients regarding their disease, therapeutic aims and options, is important for patients’ empowerment and commitment to disease management. Currently, there is no standardized and validated tool for assessment patients’ knowledge of their disease. Therefore, we aimed to develop a questionnaire to evaluate IBD patients’ understanding of disease pathophysiology and treatment. Methods We have developed the Understanding IBD Questionnaires (U-IBDQ), consisting of multiple-choice questions in two version [for Crohn’s disease (CD) and ulcerative colitis (UC)]. U-The U-IBDQ is composed of 36 questions covering 8 IBD topics. Each question received a similar weight, and total score ranges between 0–100. Questionnaires were tested for: content validity by an independent multidisciplinary stirring committee using the content validity index, face validity, readability and responsiveness on a pilot group of IBD patients. Convergent validity was assessed by correlating scores of the U-IBDQ with physician’s subjective assessment of disease understanding and knowledge. Discriminant validity was assessed by comparison to healthy controls (HC), patients with chronic gastrointestinal (GI) conditions other than IBD, and to GI nurses. A test-retest reliability was assessed among a sub-population of IBD patients which were asked to fill-in the U-IBDQ twice. Multivariate analysis was used to determine associated factors of a high level of disease understanding. Results Study population consisted of IBD patients (n=106), HC (n=35), chronic GI disease patients (n=38) and GI nurses (n=19). Mean U-IBDQ score among IBD patients was 56.5±21.9, not differing between CD and UC patients (P=0.941). There was a strong correlation between the U-IBDQ score and the physician’s subjective score (r=0.747, P&amp;lt;0.001). The U-IBDQ showed strong discriminant validity with mean score of IBD patients significantly higher than that of HC and chronic GI disease patients, and was lower than that of GI nurses (P&amp;lt;0.001). The U-IBDQ is reliable as determined by Cronbach’s alpha = 0.872. Independent factors associated with high U-IBDQ scores included academic education (OR=1.21, 95% CI 1.10–1.33, P&amp;lt;0.001), biologic therapy experience (OR=1.24, 95% CI 1.01–1.53, P=0.046), and IBD diagnosis before the age of 21 years (OR=2.97, 95% CI 1.05–8.87, P=0.050). Conclusion We have developed and meticulously validated the U-IBDQ. This is a short, self-report questionnaire that has demonstrated good reliability and validity in measuring understanding of disease pathophysiology and treatment in IBD. </jats:sec