BACKGROUND:Mucosal healing (MH) is associated with improved long-term outcomes in Crohn's disease (CD), but longitudinal pan-enteric data are limited. METHODS:This prospective observational study enrolled adults with CD initiating first-line biologic who were assessed at weeks 0, 14, 26, 52, 78, and 104 using fecal calprotectin (FCP), intestinal ultrasound (IUS), and pan-enteric video capsule endoscopy (VCE). The primary outcome was biologic discontinuation for any reason within 104 weeks. Secondary outcomes included MH (Lewis score < 135 and Eliakim score = 0) and flare-driven biologic discontinuation. Analyses used generalized estimating equations (GEE), Kaplan-Meier, and Cox models. RESULTS:Among 59 patients (median age-30 [23-43] years, male-52.5%, inflammatory phenotype-79.7%), 35 received anti-TNF, 21 vedolizumab, and 3 ustekinumab. Overall, 29 (49.2%) patients discontinued biologics after 39 (28-52) weeks, including 21 (35.6%) flare-driven discontinuations. With non-responder imputation, pan-enteric MH increased from 3.4% to 16.9%, 18.6%, and 32.2% at weeks 14, 52, and 104 (P < .001), consistent on observed-data GEE. Week-14 log-transformed FCP was most strongly associated with week-52 MH (area under the curve 0.804, 95% CI, 0.685-0.923, P = .002, optimal cutoff 172 mcg/g; lagged GEE odds ratio [OR] 0.59, 0.39-0.89, P = .012), whereas same-visit transmural remission (bowel wall thickness ≤ 3mm) showed the strongest association with MH (OR 4.97, 1.91-12.91, P = .001). Week-14 Lewis score ≥ 350 (Hazard ratio [HR] 3.18, 95% CI, 1.16-8.73, P = .025) and perianal disease (HR 3.93, 95% CI, 1.45-10.62, P = .007) were independently associated with flare-driven discontinuation. CONCLUSION:Pan-enteric MH accrues incrementally beyond year 1. Integrated FCP, IUS, and VCE assessments may optimize individualized biologic decisions in CD.
Background:Dietary interventions and multiple food-item restrictions are challenging for patients with irritable bowel syndrome (IBS), and associated with inadequate adherence. We aimed to examine the efficacy of an individualized-selective dietary intervention, based on Leukocyte activation to food-components (i.e. Alcat-guided diet) in IBS. Methods:A randomized, double-blind, sham-controlled trial allocated IBS patients at Sheba Medical Center (Ramat Gan, Israel) between 5 August 2020 and 11 April 2022 to either an Alcat-guided or a sham-balanced diet for 8-week treatment. The primary outcome was a 50-point reduction on the IBS-symptom severity scale (IBS-SSS). The rates of improvement in the IBS Global Improvement Scale (IBS-GIS) and positive response (yes/no) were defined as secondary and exploratory outcomes, respectively. Results:A total of 68 patients with IBS-D/M (44/24) were enrolled. Baseline characteristics were comparable between groups except for a higher median IBS-SSS score in the Alcat group compared with controls [390 (305-435) vs 330 (240-390), P = 0.013]. At week 8, 30 of 35 (85.7%) patients in the Alcat group met the primary outcome, compared with 18 of 33 (54.5%) of controls (P = 0.005). Alcat patients had higher rates of IBS-GIS improvement (74.3% vs 42.4%, P = 0.008) and positive response (85.7% vs 57.6%, P = 0.010) compared with controls at week 8. Among a balanced sub-cohort of patients (n = 49) with IBS-SSS score of 250-450 [median: 380 (305-410) vs 355 (310-400) for the Alcat and control groups, respectively, P = 0.487], the primary outcome was still more commonly achieved among Alcat patients compared with controls (90% vs 59%, P = 0.022). No serious adverse events were reported. Conclusion:Immune-based personalized-diet was more efficient than sham-based diet for reducing symptoms in IBS patients, and may serve as a safe treatment option in this population.
INTRODUCTION:The Bristol Stool Form Scale (BSFS) is widely used to assess stool consistency and subtype irritable bowel syndrome (IBS). METHODS:Post hoc analysis of a randomized trial comparing patient self-reported BSFS with physician-assessed BSFS. Baseline symptom severity and quality-of-life questionnaires were also collected. RESULTS:Agreement was poor across the 7-point scale (κ = -0.01, P = 0.77) and after collapsing into 3 categories (κ = 0.04, P = 0.46), with concordance in only 18/64 cases (28%). Symptom severity and quality-of-life scores were similar between concordant and discordant groups. DISCUSSION:Patient-reported BSFS may not reliably reflect stool consistency or overall IBS burden, suggesting caution when using BSFS alone for monitoring or subtyping IBS.
BACKGROUND:The Montreal classification has been widely used in Crohn's disease since 2005 to categorize patients by the age of onset (A), disease location (L), behavior (B), and upper gastrointestinal tract and perianal involvement. With evolving management paradigms in Crohn's disease, we aimed to assess the performance of gastroenterologists in applying the Montreal classification. METHODS:An online survey was conducted among participants at an international educational conference on inflammatory bowel diseases. Participants classified 20 theoretical Crohn's disease cases using the Montreal classification. Agreement rates with the inflammatory bowel diseases board (three expert gastroenterologists whose consensus rating was considered the gold standard) were calculated for gastroenterologist specialists and fellows/specialists with ≤ 2 years of clinical experience. A majority vote < 75% among participants was considered a notable disagreement. The same cases were classified using three large language models (LLMs), ChatGPT-4, Claude-3, and Gemini-1.5, and assessed for agreement with the board and gastroenterologists. Fleiss Kappa was used to assess within-group agreement. RESULTS:Thirty-eight participants from five countries completed the survey. In defining the Montreal classification as a whole, specialists (21/38 [55%]) had a higher agreement rate with the board compared to fellows/young specialists (17/38 [45%]) (58% vs. 49%, p = 0.012) and to LLMs (58% vs. 18%, p < 0.001). Disease behavior classification was the most challenging, with 76% agreement among specialists and fellows/young specialists and 48% among LLMs compared to the inflammatory bowel diseases board. Regarding disease behavior, within-group agreement was moderate (specialists: k = 0.522, fellows/young specialists: k = 0.532, LLMs: k = 0.577; p < 0.001 for all). Notable points of disagreement included: defining disease behavior concerning obstructive symptoms, assessing disease extent via video capsule endoscopy, and evaluating treatment-related reversibility of the disease phenotype. CONCLUSIONS:There is significant inter-rater disagreement in applying the Montreal classification, particularly for disease behavior in Crohn's disease. Improved education or revisions to phenotype criteria may be needed to enhance consensus on the Montreal classification.
BACKGROUND AND AIMS:Anti-tumor necrosis factor-α inhibitors (anti-TNFs) are the established treatment for perianal Crohn's disease (pCD), but relapse and non-response are common. Data on second- and third-line biologics are limited. We present the first direct comparison of second- and third-line biologics in pCD patients with active perianal disease previously treated with first-line anti-TNFs. METHODS:A multicenter retrospective cohort study included adult patients with pCD who failed first-line anti-TNF. The primary outcome was clinical perianal response, with secondary outcomes of radiological response (magnetic resonance imaging or transrectal ultrasound) and healing, and clinical remission. Propensity score matching (PSM) was used to adjust for baseline differences. RESULTS:A total of 486 pCD patients from 23 IBD centers were included, with 333/486 (68.5%) and 216/263 (82.1%) matched by PSM in the second and third-line treatment groups, respectively. In the second-line group, 62/78 (79.5%) of ustekinumab (UST)-treated patients achieved clinical perianal response, compared to 46/78 (58.9%) with vedolizumab (VDZ) (OR 4.47, 95% CI, 1.94-10.28, P < .001) and 38/78 (48.7%) with anti-TNFs (OR 5.29, 95% CI, 2.39-11.71, P < .001). In the third-line group, 38/49 (77.6%) of UST-treated patients achieved clinical perianal response, compared to 29/49 (59.2%) with VDZ (OR 9.96, 95% CI, 2.6-38.4, P < .001) and 27/49 (55.1%) with anti-TNFs (OR 12.03, 95% CI, 2.99-48.47, P < .001). UST-treated patients also had higher radiological response rates than VDZ (OR 3.28, 95% CI, 1.07-10.07, P = .038). CONCLUSION:In pCD patients failing anti-TNFs as first-line treatment, ustekinumab may be more effective than vedolizumab or another anti-TNF as second or third-line therapy.
BACKGROUND:Mucosal healing (MH) is a key treatment goal in Crohn's disease (CD). However, evidence on pan-enteric MH (PE-MH) in CD patients treated with vedolizumab remains limited. We aimed to assess vedolizumab efficacy in achieving PE-MH using PillCam Crohn's capsule. METHODS:This prospective, open-label observational study included CD patients with intestinal inflammation (SB-Lewis score [LS] ≥ 220 and/or colonic-Eliakim score [ES] > 0) who initiated vedolizumab and were followed with C-reactive protein (CRP), fecal calprotectin (FCP), and PillCam Crohn's capsule at baseline and after 14 and 52 weeks. In cases of exclusive SB involvement, colonic preparation and assessment were omitted. LS and ES were calculated when applicable. The primary outcome was PE-MH, defined as LS < 135 for SB-VCE assessment, and ES = 0 for PE-VCE assessment. Secondary outcomes included SB-MH (LS < 135), colonic-MH (ES = 0) and biochemical remission (FCP < 150 μg/g). An exploratory outcome for SB-MH was defined as a LS < 350, which has previously been shown to predict future flares in CD. RESULTS:Of the 60 screened patients, 44 were enrolled (median age: 29.0 [22.0-45.5] years; 43.2% male; Ileum [L1]-54.5%, Colon [L2]-41.0%, Ileo-colon [L3]-4.5%). At week 52, 7/44 (15.9%) patients reached PE-MH compared to baseline (risk difference [RD] 15.9%, 95% confidence interval [CI] 5.1%-26.7%, p = 0.016). 8/44 (18.2%) and 9/44 (20.5%) patients achieved SB-MH at week 52 and 14, respectively, compared to 2/44 (4.5%) at baseline. Using the less stringent SB-MH criterion (LS < 350), rates improved significantly at week 52 versus baseline (45.5% vs. 25.0%, p = 0.049). All study indices decreased during follow-up (baseline, week 14, week 52): CRP (11.8, 5.8, 5.0: p = 0.152), FCP (758, 418, 158: p = 0.004), LS (900, 225, 225, p < 0.001), and ES (18.0, 4.0, 4.0: p < 0.001). 14/44 (31.8%) patients reached biochemical remission (p = 0.049) at week 52 compared to 5/44 (11.4%) at baseline. CONCLUSION:Vedolizumab treatment led to significant biochemical and endoscopic improvement, including SB-MH and PE-MH, through 52 weeks.
BACKGROUND & AIMS:Optimal treat-to-target strategies for Crohn's disease (CD) are still being sought. The value of video capsule endoscopy (VCE) to guide proactive treat-to-target optimization in CD was examined. METHODS:A randomized controlled trial of patients with small bowel-involved (L1/L3) CD in corticosteroid-free clinical remission (Crohn's Disease Activity Index < 150). Patients ingested a VCE at baseline and those with a Lewis inflammatory score (LS) ≥ 350 were designated "high risk" and randomized to either treat-to-target treatment optimization or continued standard care. Treat-to-target was optimized by means of repeat VCE results every 6 months. Patients with LS < 350 ("low risk") continued standard care. The primary outcome was the rate of disease exacerbation (Crohn's Disease Activity Index increase > 70 points and score > 150 or hospitalization/surgery) in high-risk standard care vs treat-to-target groups at 24 months. RESULTS:Of 118 patients screened, 60 were enrolled. Treatment intensification in patients in the high-risk group allocated to proactive strategy comprised biologic dose escalation (n = 11 of 20), starting a biologic (n = 8 of 20), or swapping biologics (n = 1 of 20). The primary outcome, clinical flare by 24 months, occurred in 5 of 20 (25%) of high-risk treat-to-target patients vs 14 of 20 (70%) of the high-risk standard-care group (odds ratio, 0.14; 95% CI, 0.04-0.57; P = .006). Mucosal healing was significantly more common among the treat-to-target group when determined by a cutoff LS < 350 (odds ratio, 4.5; 95% CI, 1.7-17.4; nominal P value = .03), but not by the combined scores of total LS < 450 and highest-segment LS < 350. Among all patients continuing standard care (n = 40), baseline LS was numerically higher among relapsers vs nonrelapsers (450, 225-900 vs 225, 135-600, respectively; P = .07). Of 221 VCEs ingested, there was a single (0.4%) temporarily retained spontaneously resolved event. CONCLUSIONS:A VCE-guided treat-to-target strategy for patients with CD in remission confers superior clinical outcomes compared with continued standard care. CLINICALTRIALS:gov, Number: NCT03555058.
Background:Intestinal ultrasound (IUS) is accurate in detecting active ulcerative colitis (UC), but its role in repeated monitoring during biologic therapy remains to be established. This study aimed to assess correlations between IUS findings and the Mayo endoscopic score (MES), clinical and biochemical indices, and to evaluate the utility of IUS for monitoring infliximab (IFX) therapy and predicting outcomes. Methods:In this prospective open-label study, patients with moderate-to-severe UC starting IFX were assessed at baseline and at week 14. Flexible sigmoidoscopy, IUS and measurement of fecal calprotectin levels were performed at both time points. Correlations between bowel wall thickness (BWT) and MES, C-reactive protein (CRP), calprotectin, and the Simple Clinical Colitis Activity Index (SCCAI) were analyzed across both visits. Results:Thirty-two patients completed baseline evaluations and 21 completed follow up. Median age was 38 years; 53% were male. Disease extent was left-sided in 41% and extensive in 59%. BWT showed moderate correlations with MES (r=0.43, P=0.0015), and CRP (r=0.40, P=0.007), and a weak correlation with calprotectin (r=0.19, P=0.25). No significant differences in BWT, MES, CRP or calprotectin were observed at either time point. The only significant improvement was in SCCAI, from 7 (4.8-8) to 3 (1-5) (P=0.009). Baseline BWT and MES did not differ significantly between responders and non-responders. Conclusions:BWT measured by IUS correlates with endoscopic and biochemical markers of disease activity. IUS may serve as a reliable, noninvasive alternative to endoscopy for monitoring treatment response in UC.
Background The comprehensive evaluation of multimodal large language models (LLMs) in gastroenterological image-analysis remains limited. We aimed to assess the accuracy of the Eosinophilic Esophagitis Endoscopic Reference Score (EREFS) scoring system for Eosinophilic Esophagitis (EoE) across gastroenterology (GI) clinicians with varying levels of experience. Methods Fifty real-world endoscopic images of EoE patients were graded based on the original EREFS score by a gold standard anchor-rater. EREFS gradings of GI specialists, fellows and three multimodal LLMs (ChatGPT-4o, Claude Sonnet 3.5, Perplexity Sonar) were compared with the anchor-rater's scoring. LLMs were provided with both single-shot and few-shot prompting strategies to optimize performance. Results Overall assessment accuracy was significantly higher among GI fellows (72.4 %) compared to specialists (65.3 %, p = 0.004) and LLMs (58.9 %, p < 0.001). In the detection of edema, LLMs outperformed specialists (83.3 % vs 49.3 %, p < 0.001). However, LLMs showed significantly poor performance in rings assessment (30 %) compared to specialists (58 %) and fellows (58.7 %, both p < 0.001). After implementation of few-shot prompting, the overall performance of LLMs was comparable to GI specialists (62.7 % vs 65.3 %, p = 0.3). Conclusions This study uncovers variability in EREFS scoring across human raters with different expertise and multimodal LLMs, and demonstrates that few-shot prompting can optimize LLM accuracy.
Abstract Background Crohn’s disease (CD) complications affect 25% of patients at diagnosis and may progress to over 70% within ten years, often evolving into more complex forms. Controlling inflammation is essential to prevent disease progression, with biologics playing a central role. Video capsule endoscopy (VCE) and intestinal ultrasound (IUS) have proven effective in monitoring CD and predicting future complications. However, prospective data on pan-enteric mucosal inflammation and transmural healing in CD remain limited. Methods This prospective observational study included patients with CD who started on first-line biologics. Patients were followed at baseline, 14 weeks, and 52 weeks with assessments including CD Activity Index (CDAI), C-reactive protein (CRP), fecal calprotectin (FCP), pan-enteric VCE after confirming small-bowel patency via patency capsule (PC) ingestion, and IUS. The primary outcome was the continuation of biologic therapy after one year. Biochemical, endoscopic, and ultrasonographic remission were defined as follows: FCP<150 µg/g, Lewis score (LS)<135 or Eliakim score (ES)<4, and terminal ileum-bowel wall thickness (TI-BWT)<3 mm. Results Seventy-eight patients were screened, with 59 enrolled (median age: 30 [23-43] years; male: 31/59 [52%]; B2/3 disease phenotype: 12/59 [20.3%]), and 19 excluded (Figure, A). The patients started vedolizumab (21/59, 35%), infliximab (11/59, 19%), adalimumab (24/59, 41%) and ustekinumab (3/59, 5%). Eight patients were dropped out before the 14-week time point (Figure, A). At 52 weeks, 34/59 (58%) patients continued their biologics. Among patients with abnormal baseline biochemical, endoscopic, and ultrasonographic measures, 11/42 (26.2%) achieved biochemical normalization, 7/52 (13.5%) achieved small-bowel mucosal healing (MH), 6/38 (15.8%) achieved pan-enteric MH, and 8/28 (28.6%) achieved transmural healing at 14 weeks (Figure, B). Seventeen patients discontinued the study between the 14-week and 52-week time points (Figure, A). At 52 weeks, 17/42 (40.5%) of patients achieved biochemical normalization, 9/52 (17.3%) achieved small-bowel MH, 12/38 (31.6%) achieved pan-enteric MH, and 10/28 (35.7%) achieved transmural healing (Figure, B).All median study indices significantly improved during follow-up: CDAI: 103→64→63 (p=0.08); CRP (mg/dL): 6.6→5.0→4.1 (p=0.016); FCP (μg/g): 678→190→101 (p=0.009); LS: 750→225→225 (p<0.001); ES: 11→4→2 (p<0.001); TI-BWT (mm): 3.8→ 3.3→2.3 (p<0.001) (Figure, C). Conclusion First-line biologics significantly improve pan-enteric MH rates, along with clinical, biochemical, and ultrasonographic indices, in patients with CD over one year, with more than half of patients remaining on therapy during this period.
Background and Aims Fecal calprotectin (FC) is known to be a sensitive biomarker of colonic inflammation but to a lesser degree of small bowel (SB) inflammation. Moreover, data on FC's diagnostic levels in different SB segments are scarce. We aimed to examine FC's diagnostic levels along the SB axis in CD.Methods This was a post hoc aggregated analysis of 5 prospective studies of adult CD patients who underwent FC testing and SB video capsule endoscopy. Lewis score (LS) inflammation in different SB segments was tested for correlation with FC level after the exclusion of colonic disease. The diagnostic levels of FC for SB inflammatory topographical gradient were assessed using a receiver operating characteristic.Results Two hundred and fourteen patients were included (age: 30 [24-43] year-old, males-57%). For a similar SB inflammatory activity (LS >= 135), FC levels incrementally increased from proximal to distal SB segments (63 [30-121] vs 190 [78-549], p = 0.005) and from distal SB segment to the colon (190 [78-549] vs 542 [185-1000], p = 0.010). The best FC cutoffs to identify isolated mild proximal/distal SB inflammation (LS >= 135) were 77 mu g/g and 123 mu g/g, respectively. A cutoff of 234 mu g/g was best to detect more significant proximal inflammation (LS >= 350) when only mild distal SB inflammation was present. In sensitivity analyses, this proximal-to-distal FC gradient was maintained when LS >= 350 and LS >= 790 were used as the inflammatory reference values. Unlike FC, the magnitude of CRP elevation was unrelated to the topography of inflammation along the SB axis.Conclusions FC may serve as a topographical biomarker of CD-activity, with its sensitivity to identify mucosal inflammation increases from proximal to distal SB segments.
Capsule endoscopy has been proven as an efficient and accurate tool in the diagnosing and monitoring patients with inflammatory bowel disease, especially Crohn's disease (CD). The current European Crohn's and Colitis Organization guidelines recommend small bowel disease assessment in newly diagnosed CD, wherein small bowel capsule endoscopy (SBCE) is of prime importance. SBCE plays an essential role in assessing mucosal healing in patients with CD, serving as a monitoring tool in a treat to target strategy, and is capable of identifying high-risk patients for future flares.
Background: Inflammatory bowel disease (IBD) presents unique challenges in elderly patients due to comorbidities and treatment-related risks. Objectives: This study evaluates ustekinumab (UST) and vedolizumab (VDZ) efficacy and safety in elderly Crohn’s disease (CD) patients. Design: A retrospective cohort study at a tertiary medical center. Methods: CD patients aged ⩾60 years (elderly) treated with UST, compared to non-elderly (<60 years) patients treated with UST and elderly patients treated with VDZ. Clinical response was evaluated using the Harvey–Bradshaw index (HBI) and clinical biomarkers, alongside monitoring steroid use, hospitalization rates, treatment persistence, and surgical interventions. Results: The study included 166 CD patients: 32 elderly and 65 non-elderly patients treated with UST, and 69 elderly patients treated with VDZ. The mean duration of follow-up was 10.8 ± 2.8 months in the non-elderly group, 9.97 ± 3.28 months in the elderly UST group, and 10.0 ± 3.29 months in the VDZ group. Elderly UST patients were more likely to receive corticosteroids at initiation than non-elderly UST patients (44% vs 14%, p = 0.001). At 12 months, clinical response rates did not significantly differ between elderly and non-elderly UST groups, respectively (48% vs 40%, p = 0.5). However, elderly UST patients exhibited higher hospitalization rates over time compared to non-elderly UST patients (6-month: 19% vs 6.2%, p = 0.077; 12-month: 19% vs 4.6%, p = 0.055; log-rank p = 0.004). No significant differences were observed in clinical response and remission rates between elderly UST and elderly VDZ patients at 6 and 12 months. At 6 months, a higher hospitalization rate was observed in the UST group (19% vs 4.3% p = 0.027), but this difference did not persist over time. Conclusion: UST and VDZ are effective and safe treatments for elderly CD patients, despite higher hospitalization rates compared to non-elderly patients, likely due to age-related complications.
Patency capsule (PC) ingestion is commonly used to minimize capsule retention in high-risk patients with Crohn’s disease (CD). However, false-positive rates remain high, precluding the use of video capsule endoscopy (VCE). We aimed to compare the efficacy of two preparation protocols in reducing failed PC rates in patients with CD. This bi-center retrospective case–control study included adult patients with small-bowel CD in clinical remission who underwent PC ingestion. The pro-motility group followed a low-residue diet, then a clear fluid diet, and took bisacodyl after ingestion, while the control group followed only a clear fluid diet. The primary outcome was failed PC, defined as the absence of PC excretion or presence on abdominal X-ray at 30 h post-ingestion. Multivariable logistic regression was used to identify predictors of failed PC. Among 273 patients (83 in the pro-motility group, 190 controls), the pro-motility group was older (median 36 [27–48] vs. 31 [24–43], p = 0.012) and had a lower rate of B2/3 disease phenotype (32.5 vs. 53.1
Background: Small bowel video capsule endoscopy (SB-VCE) assesses mucosal inflammation in Crohn's disease (CD), while intestinal ultrasound (IUS) examines transmural involvement. We aimed to correlate SB-VCE with IUS in evaluating active CD and monitoring treatment response over time. Methods: Patients with active SB-CD who initiated biologics were prospectively followed with fecal calprotectin (FC), SB-VCE, and IUS at baseline and after 14 and 52 weeks. The Lewis score (LS), Limberg index (LI), and terminal ileum bowel wall thickness (TI-BWT) were documented, and the International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) was retrospectively calculated. Biochemical, endoscopic, and ultrasonographic remission were defined as FC < 150 mu g/g, LS < 135, and LI < 2 + TI-BWT <= 3 mm, respectively. A therapeutic response for each index was defined as a 25% reduction compared to baseline. Results: Seventy-one patients were included (median age: 30 years [23-43], 49.3% male). The median interval between SB-VCE and IUS was 3 days (0-25). Initially, the LS strongly correlated with TI-BWT (r = 0.647, P < .001), LI (r = 0.597, P < .001), and IBUS-SAS (r = 0.647, P < .001), but these correlations weakened over time (TI-BWT: r = 0.344, P = .002; LI: r = 0.471, P = .001; IBUS-SAS: r = 0.236, P = .122). Moderate agreement was found between ultrasonographic and endoscopic treatment responses (LS and TI-BWT: K = 0.51, P = .015; LS and LI: K = 0.44, P = .063), with fair agreement for remission (K = 0.27, P = .006). TI-BWT best cutoffs for mild (LS >= 135) and moderate-to-severe (LS >= 790) inflammation were 2.25 mm and 3.6 mm, respectively Conclusions: IUS measures are strongly correlated with VCE-inflammatory LS in active CD and may provide an assessment of endoscopic response and remission over time.
BackgroundSedation increases colonoscopy risks and prolongs recovery time. We examined whether virtual reality (VR) can substitute for sedation. The primary outcome was the overall satisfaction of patients who underwent colonoscopy with VR headset compared with patients who underwent standard sedation. Pain during the procedure, polyp detection rate (PDR), colonoscopy duration, post-colonoscopy adverse events, post-colonoscopy recovery, time-to-return to daily functions, and turnaround time at the endoscopy unit were secondary outcomes.MethodsThe study was approved by Sheba Medical Center's ethics committee IRB number 21-8177-SMC. Sixty patients were sequentially enrolled in a 1:1 ratio to either standard sedated colonoscopy or VR-unsedated procedure, and all patients signed a written informed consent. 28/30 patients successfully completed the colonoscopy using VR headset. Overall satisfaction score was comparable between the groups.ResultsThere was no difference between VR and controls in colonoscopy duration, or PDR. VR patients had numerically lower rate of post-colonoscopy adverse events than controls. The proportion of VR patients who reported resuming daily activities on the day of the procedure was significantly higher than in the control group. The VR group patients spent significantly less time in the hospital compared to the control group.ConclusionsVR technology can provide adequate substitution for sedation for most patients undergoing colonoscopy and offers comparable patient satisfaction and faster return to daily activities.
Abstract Background Mucosal healing (MH) is a paramount treatment goal in Crohn’s disease (CD). The vast majority of data pertains to MH in the colon and terminal ileum; nonetheless, proximal small-bowel involvement can be detected in up to 50% of CD patients assessed by capsule endoscopy (CE). Data regarding pan-enteric MH among patients with active CD who were treated with vedolizumab (VDZ) are lacking. We aimed to evaluate the efficacy of VDZ for achieving pan-enteric MH using pan-enteric CE. Methods This was a prospective open-label observational study. Patients with CD who have started on VDZ, were included. Patients underwent small-bowel patency-assessment using patency capsule (PC) and were followed by CE (PillCam Crohn’s, Medtronic, USA) before /within 40 days of treatment onset and after 14 and 52 weeks. In patients with exclusive small-bowel involvement, colonic preparation was not performed and colon was not assessed in subsequent CE. Accordingly, Lewis score (LS) and Pan-enteric Pillcam score (PS) were calculated, when available. The primary outcome was pan-enteric MH defined as LS<135 and LS<135 & PS<4 for CE confined to the SB/SB &colon, respectively. The main secondary outcomes were small-bowel MH (LS<135) and colonic-MH (colonic PS<4). Results 57 patients were recruited, 41 patients were enrolled (median age: 28 [23-45] years, male-44%) and 16 patients were excluded (6- retained PC, 1- technical reason, 2 -did not start VDZ, 7-withdrew consent). Of them, six patients (1- retained PC, 1- multiple strictures, 1- lost to follow-up, 3- clinical flare) and eight patients (4- discontinued VDZ, 2- capsule adverse events, 1- lost to follow-up, 1- clinical flare) were dropped-out before week 14 and week 52, respectively. Pan-enteric MH was observed in 7/39 (18%) patients at week 14, and in 7/30 (23%) patients at week 52 (two patients and 11 patients have not yet reached 14/52-week, respectively). We observed higher rates of both small-bowel MH and colonic-MH during follow-up compared to baseline (Figure 1), and it was consistent with significant improvement at week 14 in both LS (900 [225-900] vs. 450 [0-900], p<0.001) and PS (12 [2-18] vs. 6 [0-14], p=0.001) compared to baseline. Improvement was even more prominent at week 52 (LS- 0 [0-300] PS- 2 [2-6]). No cases of retained capsule were observed during follow-up. Conclusion VDZ induces MH in both the small-bowel and the colon among patients with CD, and this effect may persist up to 52 weeks of treatment.
Abstract INTRODUCTION AND AIM Patency capsule (PC) is a recommended procedure to confirm that the gastrointestinal tract is patent before ingestion of video capsule endoscopy (VCE). However, in some patients non-expelled PC may be due to slow transit time and not due to small bowel stricture. We examined if a nutritional intervention during the PC test which we introduced into routine clinical practice could improve passed PC rate and reduce false positive results. METHODS A retrospective study of patients who were subjected to standard protocol of PC procedure or to a nutrition-modified protocol of PC. Nutritional-modification comprised individualized dietary advice on the consumption of personally-convicted laxative foods after PC ingestion. Imaging study at 30 hours post-ingestion was performed to ascertain passage of PC in patients who did not visually see a passed PC in stool. RESULTS A total of 49 Crohn's patients who ingested PC were included (median age 33.7, 28.6% with previous intestinal resection). 26 patients followed the nutrition-modified personalized protocol and 23 did not (15 for technical reasons, eight for non-compliance). In total, 38 PC passed and 11 failed. Patients on dietary modification had significantly reduced rate of a failed PC compared to patients receiving standard protocol (7.7% versus 39.13%, respectively, odds ratio 0.13, 95% [CI] 0.0244-0.687, P value = 0.016). All patients with a passed PC subsequently ingested a VCE without complications. CONCLUSION Personalized nutritional intervention to promote colonic transit time may serve as a novel practical easy-to-follow dietary tool, in order to improve the diagnostic accuracy of patency capsule. Prospective controlled trials are warranted to corroborate these findings. Study flowchart. CD, Crohn’s disease; CT: Computed tomography; PC: Patency capsule. Percentage (%) of patients with failed PC with nutrition protocol or with standard protocol.
Background: Crohn’s disease (CD) and Ankylosing Spondylitis (AS) are chronic conditions with overlapping inflammatory pathways. This research investigates the genetic association between AS and the requirement for more aggressive therapeutic interventions in CD, suggesting a likelihood of increased severity in CD progression among individuals diagnosed with AS. Methods: This study utilized two-sample Mendelian randomization (TSMR) to analyze GWAS datasets for AS and CD requiring second-line treatment. Instrumental variables were selected based on single-nucleotide polymorphisms of genome-wide significance. Analytical methods included inverse-variance weighted (IVW), MR Egger, and other MR approaches, alongside sensitivity analysis, to validate the findings. Results: Our results indicated a significant association between AS genetic predisposition and the increased need for second-line treatments in CD. The IVW method showed an Odds Ratio (OR) of 2.16, and MR Egger provided an OR of 2.71, both were statistically significant. This association persisted even after the exclusion of influential outlier SNP rs2517655, confirming the robustness of our findings. Conclusions: This study suggests that genetic factors contributing to AS may influence the progression of CD, potentially necessitating more intensive treatment strategies. These findings underscore the importance of early screening in patients with co-existing AS and CD for tailoring treatment approaches, thus advancing personalized medicine in the management of these complex conditions.