Efficacy of Microencapsulated Sodium Butyrate as Add-On Therapy in Inducing Remission in Patients with Mild-To-Moderate Ulcerative Colitis: Results From a Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study - Article abstract #948912

Introduction: Patients with Inflammatory Bowel Disease (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are at high risk of developing malignancies, so prevention and adherence to cancer screening may improve detection. The aim of this study was to assess compliance with medical recommendations, especially primary and secondary prevention of cancer. Methods: This one-center cross-sectional study was carried out between June and December 2021 amongst patients at the Department of Internal Medicine and Gastroenterology, IBD Division, National Medical Institute of Ministry of Interior Affairs and Administrations, or the outpatient clinic. Patients with IBD were asked to complete an anonymous questionnaire, which included 42 questions concerning lifestyle, cancer risk factors, cancer history, and checkups. Statistical methods: The results of the qualitative variables were expressed as frequencies and percentages. We used Fisher’s exact test and the Chi-squared test. A value of p < 0.05 was considered significant. Statistical analyses were performed with the SPSS statistical package. Results: A total of 313 patients were enrolled in the study: 145 women and 168 men. In the group, 182 had Crohn’s disease (CD), 120 had ulcerative colitis (UC), and 11 with IBDU (unclassified IBD). Most participants had a disease duration of over 8 years and received biological treatment, corticoids, and/or immunosuppressive therapy. Amongst respondents, 17% (31) of patients with CD and 25.8% (31) with UC were overweight, and 10.5% (19) with CD and 15.8% (19) with UC were obese (p = 0.017). We found that 16.3% of all respondents were smokers (79.6% (144) with CD, 90.8% (109) with UC, and 72.7% (8) with IBDU; p = 0.053), and 33.9% declared that they consumed alcohol (39.4% (71) with CD, 26.9% (32) with UC, and 18.2% (2) with IBDU; p = 0.045). A total of 25.4% of patients were exposed to UV radiation, but only 18.8% used sunblock. In addition, 58.8% (67) of patients with CD and 35.8% (19) with UC receiving immunosuppressants had regular laboratory tests (p = 0.02). Furthermore, 41.4% (46) of patients with UC, 27.1% (49) of patients with CD, and 70.0% (7) of patients with IBDU declared not to perform any dermatological control (p = 0.013). A total of 77% of patients had abdominal ultrasound. Out of 52.9% of patients for whom colonoscopy was recommended, only 27.3% had it performed (16.9% (30) with CD vs. 43.1% (50) with UC p < 0.001). Most examinations were ordered by gastroenterologists. Female patients had regular breast control (CD, 78.6% (66); UC, 91.2% (52); IBDU, 50% (2); p = 0.034), and 93.8% (76) had gynecological examinations. Additionally, 80.2% of patients knew about HPV, but most declared not to be vaccinated. A total of 17.9% of patients had urological control, but most had no important pathology detected. Conclusions: According to our study, many patients are still exposed to risk factors, such as obesity, smoking, and low physical activity, that are modifiable. Laboratory tests in patients with immunosuppressive treatment should be performed regularly. Systematic control, especially dermatological checkups, should be recommended. Additionally, not only gastrologists but also other specialists and GPs should remind patients about regular checkups. Primary prevention, such as HPV vaccinations, should be recommended to all patients.

Sodium butyrate (SB), a salt of the short-chain fatty acid butyrate, has emerged as a promising adjunctive therapy in inflammatory bowel disease (IBD). IBD is commonly associated with intestinal dysbiosis characterized by depletion of butyrogenic bacteria. This leads to a functionally relevant...

Introduction Effective prediction of endoscopic remission is a key to optimizing ulcerative colitis (UC) management. While fecal calprotectin (FC) is widely used, its limitations highlight the need for complementary biomarkers. This study evaluated fecal butyric acid (C4) as a novel,...

Background: Inflammatory bowel disease (IBD) encompasses chronic gastrointestinal disorders that significantly impact patients’ quality of life (QoL). While clinical trials support the efficacy and safety of vedolizumab, real‐world data linking its effectiveness to QoL‐related patient‐reported outcomes remain limited. This prospective observational study assessed the effects of 14‐week vedolizumab induction therapy on QoL (i.e., fatigue, mood, and sleep disturbances), clinical response, safety, and predictors of response. Methods: A total of 257 patients with ulcerative colitis (UC; n = 205) and Crohn’s disease (CD; n = 52) received 14‐week vedolizumab induction therapy. Disease activity, QoL (assessed using the total Inflammatory Bowel Disease Questionnaire [IBDQ]), fatigue (Functional Assessment of Chronic Illness Therapy‐Fatigue [FACIT‐Fatigue]), mood and sleep disturbances (PROMIS Depression and Sleep Disturbance scales), and selected biomarkers were evaluated. Clinical response was assessed using the Mayo score for UC and Crohn’s Disease Activity Index (CDAI) score for CD. Results: At Week 14, clinical response was observed in 82% of UC patients and 82.7% of CD patients. Median total IBDQ scores increased by 45.0 points in UC and 31.5 points in CD ( p < 0.001). Median prorated FACIT‐Fatigue scores increased by 5.0 points in both groups ( p < 0.001), while median prorated PROMIS Sleep Disturbance and Depression T‐scores decreased ( p < 0.05). Improvement in QoL was moderately correlated with clinical response ( r = 0.5). In logistic regression analysis, baseline patient characteristics indicative of advanced disease were associated with a reduced likelihood of clinical and QoL response to treatment. A total of 28 adverse events were reported, including 11 serious events and four treatment‐related events. Conclusions: Vedolizumab reduced disease activity and led to a rapid improvement in QoL during the 14‐week induction therapy in patients with IBD. Clinical response was positively correlated with QoL improvement. Predictors of reduced response were consistent with features of advanced disease.