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Reevaluating Stemness in the Intestinal Crypt 重新评估肠隐窝中的干细胞。
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2024.09.010
Samuel Asfaha, Nicola L. Jones
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引用次数: 0
Use of Large Language Models to Identify Surveillance Colonoscopy Intervals—A Feasibility Study 使用大型语言模型确定结肠镜检查监测时间间隔--可行性研究
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2024.09.032
Vedant Acharya, Vignesh Kumaresan, Jonathan England, Shivan Mehta, Daniel Sussman, Amar Deshpande
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引用次数: 0
Safety and Tolerability of CP101, a Full-Spectrum, Oral Microbiome Therapeutic for the Prevention of Recurrent Clostridioides difficile Infection: A Phase 2 Randomized Controlled Trial 用于预防艰难梭菌复发感染的全方位口服微生物组疗法 CP101 的安全性和耐受性：2期随机对照试验。
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2024.09.030
Jessica R. Allegretti , Colleen R. Kelly , Thomas Louie , Monika Fischer , Susy Hota , Bharat Misra , Nick W. Van Hise , Eugene Yen , Jeffrey S. Bullock , Michael Silverman , Ian Davis , Sarah K. McGill , Darrell S. Pardi , Robert Orenstein , Ari Grinspan , Najwa El-Nachef , Paul Feuerstadt , Thomas J. Borody , Sahil Khanna , Shrish Budree , Zain Kassam

Background & Aims

Recurrent Clostridioides difficile infections (CDIs) remain common. While novel microbiome therapeutics gain approval, the efficacy of a full-spectrum, oral microbiome therapeutic is unknown. This study aimed to determine the safety and efficacy of CP101, an orally administered microbiome therapeutic, to restore a diverse microbiome and prevent recurrent CDI in a broad population.

Methods

We conducted a multicenter, phase 2, double-blind, randomized, placebo-controlled trial in adults with recurrent CDI. Participants with one or more CDI recurrences and diagnosis by polymerase chain reaction or toxin enzyme immunoassay for the qualifying episode were included. Participants were randomized 1:1 to receive a single oral dose of either CP101 (∼6 × 1011 colony-forming units of lyophilized microbial cells) or placebo after standard-of-care antibiotics. The primary efficacy endpoint was the proportion of participants without CDI recurrence through week 8. Safety, efficacy, and microbiome endpoints were evaluated through weeks 8 and 24.

Results

A total of 198 participants were analyzed: CP101 (n = 102) and placebo (n = 96). Overall, 27.5% had a first recurrence, and 62.7% were diagnosed by polymerase chain reaction–based testing. The proportion without CDI recurrence through week 8 was significantly higher in the CP101 group compared to the placebo group (74.5% [76 of 102] vs 61.5% [59 of 96], respectively; P = .0488), with durable efficacy observed through week 24 (73.5% [75 of 102] vs 59.4% [57 of 96], respectively; P = .0347). Similar efficacy was observed regardless of diagnostic modality or number of CDI recurrences. Rapid and durable increase in microbiome diversity was observed in the CP101 group compared to the placebo group. The incidence of adverse events was similar between the 2 groups.

Conclusions

CP101 was superior to placebo in reducing recurrent CDI with a safety profile similar to placebo. (ClinicalTrials.gov, Number NCT03110133)
背景和目的复发性艰难梭菌感染（CDI）仍然很常见。虽然新型微生物组疗法已获得批准，但全方位口服微生物组疗法的疗效尚不清楚。本研究旨在确定口服微生物组疗法 CP101 的安全性和疗效，以在广泛人群中恢复多样化的微生物组并预防复发性 CDI。方法我们在复发性 CDI 成人患者中开展了一项多中心、2 期、双盲、随机、安慰剂对照试验。试验对象包括复发过一次或多次 CDI 并经 PCR 或毒素 EIA 诊断为合格病例的患者。参与者按 1:1 随机分配，在使用标准护理 (SOC) 抗生素后，接受单剂量口服 CP101（6 x 1011 CFU 的冻干微生物细胞）或安慰剂。主要疗效终点是在第 8 周内无 CDI 复发的参与者比例。对第8周和24周的安全性、疗效和微生物组终点进行了评估，分析了198名参与者的结果；CP101（n=102）和安慰剂（n=96）。总体而言，27.5%的患者首次复发，62.7%通过PCR检测确诊。与安慰剂相比，CP101 组在第 8 周未复发 CDI 的比例明显更高（74.5% [76/102] vs 61.5% [59/96]，p=0.0488），且疗效持续到第 24 周（73.5% [75/102] vs 59.4% [57/96]，p=0.0347）。无论诊断方式或CDI复发次数如何，都观察到了相似的疗效。与安慰剂相比，CP101 组的微生物群多样性出现了快速而持久的增长。两组的不良反应发生率相似。结论CP101在减少CDI复发方面优于安慰剂，其安全性与安慰剂相似。https://clinicaltrials.gov/study/NCT03110133。
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引用次数: 0
Placebo Rates in Crohn’s Disease Randomized Clinical Trials: An Individual Patient Data Meta-Analysis 克罗恩病随机临床试验中的安慰剂比例：患者个体数据荟萃分析
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2024.10.009
Virginia Solitano , Malcolm Hogan , Siddharth Singh , Silvio Danese , Laurent Peyrin-Biroulet , Guangyong Zou , Yuhong Yuan , Bruce E. Sands , Brian G. Feagan , Parambir S. Dulai , Neeraj Narula , Christopher Ma , Vipul Jairath

Background & Aims

Understanding placebo rates is critical for efficient clinical trial design. We assessed placebo rates and associated factors using individual patient data from Crohn’s disease trials.

Methods

We conducted a meta-analysis of phase 2/3 placebo-controlled trials evaluating advanced therapies in moderate to severe Crohn’s disease (2010–2021). Deidentified individual patient data were obtained through Vivli Inc and the Yale University Open Data Access Project. Primary outcomes were clinical response and remission. Pooled placebo rates and 95% confidence intervals (CIs) were estimated using 1- and 2-stage meta-analytic approaches. Regression analyses identified patient-level factors associated with placebo rates.

Results

Analysis of individual patient data from 8 induction (n = 1147) and 4 maintenance (n = 524) trials showed overall placebo clinical response and remission rates for induction were 27% (95% CI, 23%–32%) and 10% (95% CI, 8%–14%), respectively, and 32% (95% CI, 23%–42%) and 22% (95% CI, 14%–33%) for maintenance, respectively. Among biologic (bio)-naïve patients, placebo response and remission rates during induction were 29% (95% CI, 24%–35%) and 11% (95% CI, 8%–15%) respectively, and 26% (95% CI, 20%–33%) and 10% (95% CI, 8%–14%) for biologic (bio)-exposed patients, respectively. During maintenance, biologic-naïve response and remission rates were 41% (95% CI, 34%–48%) and 32% (95% CI, 24%–40%), respectively, and 29% (95% CI, 24%–34%) and 16% (95% CI, 13%–21%) for bio-exposed, respectively. Higher baseline C-reactive protein concentration predicted lower placebo rates, whereas higher baseline albumin levels and body mass index increased the odds of placebo outcomes. Increased baseline Crohn’s Disease Activity Index and 2-item patient-reported outcome scores predicted higher response rates in induction, lower response rates in maintenance, and lower remission rates in induction and maintenance.

Conclusions

Patient- and trial-level characteristics influence placebo rates in Crohn’s disease trials. Careful implementation of eligibility criteria, outcome definitions, and patient stratification may reduce placebo rates.
背景& 目的了解安慰剂使用率对于高效的临床试验设计至关重要。我们利用克罗恩病（CD）试验中的患者个体数据（IPD）评估了安慰剂率及相关因素。方法我们对评估中重度CD晚期疗法的2/3期安慰剂对照试验（2010-2021年）进行了荟萃分析。通过 Vivli 公司和耶鲁大学开放数据访问项目获得了去标识化 IPD。主要结果为临床反应和缓解。采用一阶段和两阶段荟萃分析方法估算了汇总安慰剂率和 95% 置信区间 (CI)。结果利用 8 项诱导试验（n=1147）和 4 项维持试验（n=524）的 IPD，诱导试验的总体安慰剂临床应答率和缓解率分别为 27% (95%CI=23-32%) 和 10% (95%CI=8-14%)，维持试验的总体安慰剂临床应答率和缓解率分别为 32% (95%CI=23-42%) 和 22% (95%CI=14-33%)。在生物无效患者中，诱导期安慰剂应答率和缓解率分别为29%（95%CI=24-35%）和11%（95%CI=8-15%），生物暴露期分别为26%（95%CI=20-33%）和10%（95%CI=8-14%）。在维持治疗期间，生物无效反应率和缓解率分别为41%（95%CI=34-48%）和32%（95%CI=24-40%），生物暴露率分别为29%（95%CI=24-34%）和16%（95%CI=13-21%）。较高的基线C反应蛋白浓度预示着较低的安慰剂比例，而较高的基线白蛋白水平和体重指数则增加了安慰剂结果的几率。较高的基线克罗恩病活动指数和2项患者报告结果评分预示着较高的诱导应答率、较低的维持应答率以及较低的诱导和维持缓解率。谨慎执行资格标准、结果定义和患者分层可降低安慰剂使用率。
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引用次数: 0
Methodology of Study on GLP-1 Receptor Agonists and Hepatocellular Carcinoma Risk GLP-1 受体激动剂与肝细胞癌风险的研究方法
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2024.09.037
James Cheng-Chung Wei, Poi Kuo, Qi Mei
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引用次数: 0
Enhancing Cold Snare Endoscopic Mucosal Resection: Addressing Efficacy Concerns and Margin Management 加强冷卡式内镜黏膜切除术：解决疗效问题和边缘管理
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2024.09.040
Jia Xu, Xiaowei Tang
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引用次数: 0
CHRONICLE Trial: How Cool Is Cold Snaring for Endoscopic Mucosal Resection? CHRONICLE试验：内镜粘膜切除术中的冷鼾有多酷？
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2024.06.041
Avinash Tiwari
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引用次数: 0
ORBITAL MYOSITIS AS AN EXTRAINTESTINAL MANIFESTATION OF IBD
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2025.01.101
Dheeraj Reddy, Claire Sweeney, Bincy Abraham, Poojasree Pasupuleti, Amina Malik, Andrew Lee, Christopher Fan
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引用次数: 0
COMPARATIVE EFFICACY OF JANUS KINASE INHIBITORS VERSUS USTEKINUMAB IN ULCERATIVE COLITIS TREATMENT: A SYSTEMATIC REVIEW AND META-ANALYSIS
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2025.01.068
Maram Albandak, Shahem Abbarh, Bisher Sawaf, Yusuf O. Hallak, Mohammed Abu-Rumaileh, Sana Rabeeah, Aya Akhras, Mohammad Alhayek, Wael Dahhan, Yaseen Alastal
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引用次数: 0
SAFETY OF JANUS KINASE INHIBITORS FOR THE MANAGEMENT OF OLDER ADULTS WITH INFLAMMATORY BOWEL DISEASE
IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Gastroenterology
Pub Date : 2025-02-01 DOI: 10.1053/j.gastro.2025.01.178
Zoe Memel, Nicole Garcia, Yuntao Zou, Anna Thiemann, Cooper Dort, Kendall Beck
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