Clinical and Experimental Gastroenterology最新文献

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Infliximab Serum Level Assessment After Switching from Intravenous to Subcutaneous Administration: The ISLASIS Study. 英夫利昔单抗从静脉注射转为皮下注射后的血清水平评估:islis研究。
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-10-06 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S633963
Bianca Loyo Pona Schiavetti, Rodrigo Galhardi Gasparini
{"title":"Infliximab Serum Level Assessment After Switching from Intravenous to Subcutaneous Administration: The ISLASIS Study.","authors":"Bianca Loyo Pona Schiavetti, Rodrigo Galhardi Gasparini","doi":"10.2147/CEG.S633963","DOIUrl":"https://doi.org/10.2147/CEG.S633963","url":null,"abstract":"<p><strong>Introduction: </strong>Subcutaneous infliximab (SC-IFX) has emerged as an alternative maintenance therapy for inflammatory bowel disease (IBD), offering absorption and sustained systemic exposure. Although higher and more stable serum concentrations have been reported with SC-IFX, prospective real-world data evaluating pharmacokinetic evolution after transition from intravenous infliximab (IV-IFX) remain limited, particularly in Latin America. We assessed infliximab trough concentrations following transition from IV-IFX to SC-IFX and explored associations with biomarkers and clinical outcomes.</p><p><strong>Methods: </strong>ISLASIS was a prospective, open-label study including adults with Crohn's disease (CD) or ulcerative colitis (UC) receiving IV-IFX. All transitioned to SC-IFX and were evaluated at baseline (V1), week 12 (V2), and week 24 (V3). Infliximab trough concentrations were measured at each visit. Fecal calprotectin and clinical indices were assessed at baseline and week 24. Subgroup analyses explored pharmacokinetic behavior according to disease phenotype, prior biologic exposure, and IV regimen.</p><p><strong>Results: </strong>Nineteen patients were included; 89.5% had CD, with 35.3% presenting perianal disease. Median trough concentrations increased from 8.7 μg/mL at baseline to 20.0 μg/mL at week 12 and remained at 20.0 μg/mL at week 24 (p=0.00029). Fecal calprotectin decreased from 239 to 142 μg/g (p=0.00097). Median Harvey-Bradshaw Index decreased from 8 to 3, while partial Mayo score declined from 2 to 0. Increases in serum infliximab concentrations were observed across the clinical and treatment subgroups evaluated, although interpretation of concentrations above 20 µg/mL was limited by the assay measurement range. No anti-infliximab antibodies were detected. One mild, self-limited injection-site reaction occurred.</p><p><strong>Conclusion: </strong>Transition from IV-IFX to SC-IFX was associated with rapid and sustained increases in trough concentrations, reductions in fecal calprotectin, and favorable changes in clinical activity scores. These findings should be interpreted in light of the small sample size and the upper measurement limit of the infliximab assay.</p><p><strong>Clinical trial registration: </strong>This investigator-initiated prospective observational study was not registered in a clinical trial registry because treatment allocation was not determined by the study protocol. All participants received standard-of-care treatment, and the decision to switch from intravenous to subcutaneous infliximab was made as part of routine clinical practice.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"633963"},"PeriodicalIF":2.6,"publicationDate":"2026-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13653526/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149166638","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Clinical and Psychosocial Burden of Inflammatory Bowel Disease Among Transgender Individuals: A National BioResource Cohort Study. 跨性别人群炎症性肠病的临床和社会心理负担:一项国家生物资源队列研究
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-10-02 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S633494
Michael Colwill, Richard Pollok, Chandni Radia, Leighton J Seal, Andrew Poullis
{"title":"Clinical and Psychosocial Burden of Inflammatory Bowel Disease Among Transgender Individuals: A National BioResource Cohort Study.","authors":"Michael Colwill, Richard Pollok, Chandni Radia, Leighton J Seal, Andrew Poullis","doi":"10.2147/CEG.S633494","DOIUrl":"10.2147/CEG.S633494","url":null,"abstract":"<p><strong>Purpose: </strong>Transgender and gender non-conforming (TGNC) individuals are under-represented in inflammatory bowel disease (IBD) research, and little is known about their diagnostic experiences, disease burden, mental health comorbidity, or quality of life (QoL). We therefore aimed to characterise clinical features, diagnostic timelines, comorbidity, and QoL among TGNC people with IBD and to contextualise key outcomes using a matched cisgender cohort.</p><p><strong>Patients and methods: </strong>We conducted a nationwide cohort study within the IBD BioResource population. Using questionnaires and linked BioResource data, we collected information on demographics, clinical history, gender-affirming care, comorbidity, and QoL. TGNC participants were matched to cisgender controls by sex and age category for a contextual and exploratory comparison. Analyses were performed using regression models.</p><p><strong>Results: </strong>Thirty-nine TGNC participants responded (46.2% Crohn's disease, 43.6% ulcerative colitis, 10.3% IBD-unclassified). Median time from symptom onset to diagnosis was 10.5 months (interquartile range 6.0-18.0), 62.3% reported prior hospitalisation and 28.2% prior IBD surgery. Psychiatric comorbidity was frequent (79%). Gender-affirming hormone therapy was reported in 30.7% and prior gender-affirming surgery in 17.9%. Matched analyses demonstrated a trend towards longer diagnostic delays and higher rates of hospitalisation and IBD-related surgery in TGNC participants. Psychiatric comorbidity was significantly higher (79.5% vs 56.8%, <i>p</i>=0.033). QoL impairment was substantial and broadly comparable between groups.</p><p><strong>Conclusion: </strong>TGNC individuals with IBD demonstrated a high burden of psychiatric comorbidity and signals of longer diagnostic timelines and poorer disease control compared with cisgender peers. These findings highlight potential disparities across IBD care pathways and underscore the need for larger, dedicated studies.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"633494"},"PeriodicalIF":2.6,"publicationDate":"2026-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13641002/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149104983","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Long-Term Safety of Ontamalimab in Patients with Moderate to Severe Inflammatory Bowel Disease. 昂他马利单抗治疗中重度炎症性肠病患者的长期安全性
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-10-01 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S618654
Geert D'Haens, Séverine Vermeire, Walter Reinisch, Silvio Danese, William J Sandborn, Stefan Schreiber, Stephen Hanauer, Caleb Bliss, Fabio Cataldi, Martina Goetsch, Kenneth J Gorelick, Michelle Mendoza, Péter Nagy
{"title":"Long-Term Safety of Ontamalimab in Patients with Moderate to Severe Inflammatory Bowel Disease.","authors":"Geert D'Haens, Séverine Vermeire, Walter Reinisch, Silvio Danese, William J Sandborn, Stefan Schreiber, Stephen Hanauer, Caleb Bliss, Fabio Cataldi, Martina Goetsch, Kenneth J Gorelick, Michelle Mendoza, Péter Nagy","doi":"10.2147/CEG.S618654","DOIUrl":"https://doi.org/10.2147/CEG.S618654","url":null,"abstract":"<p><strong>Purpose: </strong>Although ontamalimab showed promise for treatment of patients with ulcerative colitis (UC) and Crohn's disease (CD), the Phase 3 clinical development program was terminated in 2020. Here we report the results of a long-term safety (LTS) extension study.</p><p><strong>Patients and methods: </strong>The study enrolled patients with UC or CD who previously participated in the randomized, placebo-controlled phase 3 induction and maintenance clinical trials that evaluated the efficacy and safety of ontamalimab. During the LTS study, patients received ontamalimab 25 mg or 75 mg once every 4 weeks or were switched from 25 mg to 75 mg. Long-term safety outcomes, including the frequency and severity of adverse events (AEs), were assessed in eligible patients for up to 6 years of treatment. Efficacy was not formally evaluated in this study.</p><p><strong>Results: </strong>Long-term safety was evaluated in 516 patients with UC and 41 patients with CD. Across all ontamalimab dose groups in UC, 392 patients (76.0%) had AEs; 115 serious AEs occurred in 82 patients (15.9%) and 2 AEs led to patient deaths during the study. Across all ontamalimab dose groups in CD, 29 patients (70.7%) had AEs; 10 serious AEs occurred in 8 patients (19.5%) and 1 AE led to a patient death during the study. Deaths were not related to receiving ontamalimab. In patients with UC and CD, 245/253 and 18/19 who completed the study, respectively, had a treatment response at the study end.</p><p><strong>Conclusion: </strong>Ontamalimab was well tolerated and had an acceptable long-term safety profile in patients with UC and CD.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"618654"},"PeriodicalIF":2.6,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13637503/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149104940","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Beyond the Pancreas: The Gut Microbiota in Acute Pancreatitis - From Mechanisms to Therapeutic Perspectives. 超越胰腺:急性胰腺炎的肠道微生物群-从机制到治疗观点。
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-09-11 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S636881
Serge Chooklin, Serhii Chuklin
{"title":"Beyond the Pancreas: The Gut Microbiota in Acute Pancreatitis - From Mechanisms to Therapeutic Perspectives.","authors":"Serge Chooklin, Serhii Chuklin","doi":"10.2147/CEG.S636881","DOIUrl":"10.2147/CEG.S636881","url":null,"abstract":"<p><p>Acute pancreatitis is a heterogeneous inflammatory disease in which severe forms are frequently complicated by intestinal barrier failure, dysbiosis, bacterial translocation, infected necrosis, systemic inflammation, and organ dysfunction. Growing clinical and experimental evidence suggests that the gut microbiota may contribute to disease progression and represents a potential, although incompletely validated, therapeutic target. Importantly, acute pancreatitis-associated dysbiosis involves not only taxonomic shifts but also functional metabolic reprogramming, including reduced short-chain fatty acid production, altered microbial bile acid transformation, and disturbances in amino acid and lipid metabolism that may contribute to barrier dysfunction and systemic inflammation. This review synthesizes current evidence on microbiota-oriented strategies in acute pancreatitis, with emphasis on clinical applicability, mechanistic rationale, and safety. This narrative review integrates clinical guidelines, randomized trials, meta-analyses, cohort studies, metagenomic and metabolomic investigations, and experimental studies published mainly between 2002 and 2026. Among clinically supported strategies, early oral or enteral nutrition has the strongest evidence base and may help preserve mucosal integrity while limiting the ecological consequences of fasting and critical illness. Antimicrobial stewardship is also fundamental, because unnecessary antibiotic exposure may aggravate dysbiosis, impair colonization resistance, and promote resistant organisms. Selective digestive decontamination has historical clinical evidence but is not established for routine contemporary practice. Prebiotics, dietary fibers, postbiotics, and metabolite-oriented approaches are mechanistically promising, but clinical evidence remains limited. GV-971 is currently supported predominantly by preclinical experimental data. Probiotics and synbiotics require caution, particularly in predicted severe disease, because clinical benefits are inconsistent and important safety concerns have been reported. Fecal microbiota transplantation and washed microbiota transplantation remain investigational and should not be used routinely outside controlled protocols. At present, microbiota-oriented management should prioritize evidence-based supportive measures, particularly early oral or enteral nutrition and rational antimicrobial use. Future studies should combine clinical outcomes with standardized microbiome, metabolome, barrier, and resistance endpoints to determine whether direct microbiota modulation can become a safe and reproducible component of personalized therapy.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"636881"},"PeriodicalIF":2.6,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13576865/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148976012","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Dual Therapy for Complex Inflammatory Bowel Disease: Safety, Clinical and Steroid-Free Response. 复杂炎症性肠病的双重治疗:安全性、临床和无类固醇反应。
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-09-11 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S632373
Anne-Mette Haase, Jens Kelsen, Jørgen Agnholt, Mia Bendix
{"title":"Dual Therapy for Complex Inflammatory Bowel Disease: Safety, Clinical and Steroid-Free Response.","authors":"Anne-Mette Haase, Jens Kelsen, Jørgen Agnholt, Mia Bendix","doi":"10.2147/CEG.S632373","DOIUrl":"10.2147/CEG.S632373","url":null,"abstract":"<p><strong>Objective: </strong>Remission in patients with inflammatory bowel disease appears to plateau at 30-50% within the first year of biological monotherapy. Patients with Crohn's disease (CD) and ulcerative colitis (UC) on monotherapy with biologics or small molecules may face this therapeutic ceiling, not reaching remission in relation to bowel inflammation and/or extraintestinal manifestations (EIM). Dual therapy, combining two advanced therapies, has been proposed for this challenging population. We aimed to investigate real-life safety, steroid free- and clinical response in dual therapy.</p><p><strong>Materials and methods: </strong>Medical records from September 2018 to September 2023 were reviewed for CD and UC patients undergoing dual therapy with biologics and/or small molecules due to refractory bowel inflammation or EIM in outpatient gastroenterology clinics at Aarhus University Hospital and Regional Hospital Randers. Patients treated for at least three months were included and followed until treatment discontinuation or the end of the study. Patient characteristics, clinical outcomes, adverse events, and clinical response data were collected at baseline and follow-up.</p><p><strong>Results and conclusions: </strong>Seventy-four patients (47 with CD and 27 with UC) received a total of 79 dual therapies. The median dual therapy duration was 488 days for CD and 412 days for UC. The most common combinations were adalimumab/ustekinumab in CD (46%) and adalimumab/vedolizumab in UC (35%). Clinical response at follow-up was achieved in 50% of CD patients and 45% of UC patients and steroid-free follow-up in 80% of CD patients and 52% of UC patients. Severe adverse events (SAEs) occurred in eight out of 79 dual therapies. Treatment failure and adverse events within the first three months of dual therapy were not included. This study demonstrates substantial rate of clinical response and an acceptable safety profile in complex IBD patients receiving dual therapy. Still, the risk of SAEs must be balanced against the therapeutic benefit.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"632373"},"PeriodicalIF":2.6,"publicationDate":"2026-09-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13576839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148975952","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Arterial Hypertension is Associated with a Lower Portal Hypertensive Burden in Compensated Cirrhosis: A Retrospective Cohort Study. 代偿性肝硬化患者动脉高血压与门静脉高压负担降低相关:一项回顾性队列研究。
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-09-05 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S617296
Raffaele Buono, Marzia La Franca, Paolo Girardi, Marco Di Pascoli
{"title":"Arterial Hypertension is Associated with a Lower Portal Hypertensive Burden in Compensated Cirrhosis: A Retrospective Cohort Study.","authors":"Raffaele Buono, Marzia La Franca, Paolo Girardi, Marco Di Pascoli","doi":"10.2147/CEG.S617296","DOIUrl":"10.2147/CEG.S617296","url":null,"abstract":"<p><strong>Background and aims: </strong>While systemic arterial pressure typically declines with advancing cirrhosis, the relationship between arterial hypertension (AH) and clinical outcomes in compensated cirrhosis is not defined. We aimed to investigate the association between AH and non-invasive markers of portal hypertension and liver-related complications.</p><p><strong>Methods: </strong>We conducted a retrospective cohort study including 189 patients with compensated liver cirrhosis, stratified according to history of AH. Clinical, laboratory, endoscopic, and outcome data, including cirrhosis decompensation, liver transplantation, and mortality, were collected. Median follow-up time was 5 years, IQR 3.2-5.0 years. Spleen diameter was assessed at baseline and serially during follow-up.</p><p><strong>Results: </strong>Of the 189 patients, 111 had a history of AH. Compared with non-hypertensive patients, those with AH were older, had higher platelet counts, smaller spleen diameter, and fewer indirect signs of portal hypertension, including esophageal varices, congestive gastropathy, and portosystemic shunts (all p < 0.05). During follow-up, spleen size remained stable in hypertensive patients, whereas a progressive increase in spleen diameter was observed in patients without AH. Despite these differences, no significant differences were found between groups in terms of cirrhosis decompensation or overall mortality. However, patients without AH had a significantly higher rate of liver transplantation (p = 0.008).</p><p><strong>Conclusion: </strong>In compensated cirrhosis, AH is associated with fewer indirect signs of portal hypertension, including smaller and stable spleen size. These findings support the concept that patients with AH exhibit a distinct hemodynamic phenotype, characterized by less pronounced portal hypertensive state and circulatory dysfunction.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"617296"},"PeriodicalIF":2.6,"publicationDate":"2026-09-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13559884/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148944446","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Optimization of DMH-Induced Colorectal Carcinogenesis in Rats: A Systematic Meta-Review. dmh诱导大鼠结直肠癌的优化:一项系统的meta综述。
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-08-24 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S629447
Alireza Salehi, Fatemeh Yaghoobi, Mostafa Kami, Hamila-Sadat Hashemi Maivan, Hamidreza Habibi, Mohammadreza Mehraban, Sarah Gholami
{"title":"Optimization of DMH-Induced Colorectal Carcinogenesis in Rats: A Systematic Meta-Review.","authors":"Alireza Salehi, Fatemeh Yaghoobi, Mostafa Kami, Hamila-Sadat Hashemi Maivan, Hamidreza Habibi, Mohammadreza Mehraban, Sarah Gholami","doi":"10.2147/CEG.S629447","DOIUrl":"10.2147/CEG.S629447","url":null,"abstract":"<p><p>Colorectal cancer (CRC) remains a major global health concern, and experimental animal models continue to play a key role in understanding its development and in evaluating preventive and therapeutic strategies. Among these, the 1,2-dimethylhydrazine (DMH)-induced rat model is widely used; however, substantial variability in dosing regimens and study design has limited consistency across studies. The present systematic review aimed to synthesize existing evidence on DMH-induced colorectal carcinogenesis in rats, with particular attention to how dose, duration, and route of administration influence pathological outcomes. A comprehensive literature search was conducted across PubMed, Scopus, and Web of Science from January 2010 to December 2025. Eligible studies were screened and analyzed based on predefined inclusion criteria. Data were extracted on induction protocols, histopathological findings, and study characteristics. Across the 430 included studies, notable heterogeneity was observed in experimental protocols. Nevertheless, certain patterns emerged. Higher-dose, shorter-duration regimens were more frequently associated with early preneoplastic lesions such as aberrant crypt foci (ACF), whereas lower-dose, longer-duration protocols tended to be linked with more advanced tumor development. Subcutaneous administration appeared to provide more consistent results compared to other routes. These findings suggest that the choice of protocol should be guided by the intended stage of carcinogenesis under investigation. Importantly, the interpretation of these findings should be approached with caution. Many studies lacked detailed reporting of methodological parameters, and quantitative synthesis was limited by incomplete data. As such, the proposed framework should be viewed as a practical guide rather than a definitive standard. In conclusion, DMH-induced CRC models in rats remain valuable but highly sensitive to experimental design. Greater standardization and more rigorous reporting are needed to improve reproducibility and strengthen the translational relevance of future studies.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"629447"},"PeriodicalIF":2.6,"publicationDate":"2026-08-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13523867/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148849941","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Advancing Equity and Patient Partnership in Clinical Trials for Inflammatory Bowel Disease: A Model for Inclusive Trial Design. 促进炎症性肠病临床试验的公平性和患者合作:一个包容性试验设计模型。
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-08-21 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S603005
David T Rubin, Andres Yarur, Renika Wood, Brian Po-Han Chen, Lisa E Young, Megan Gower, Vijay Yajnik
{"title":"Advancing Equity and Patient Partnership in Clinical Trials for Inflammatory Bowel Disease: A Model for Inclusive Trial Design.","authors":"David T Rubin, Andres Yarur, Renika Wood, Brian Po-Han Chen, Lisa E Young, Megan Gower, Vijay Yajnik","doi":"10.2147/CEG.S603005","DOIUrl":"10.2147/CEG.S603005","url":null,"abstract":"<p><strong>Purpose: </strong>Efficacy rates of advanced therapies for inflammatory bowel disease (IBD) may be improved by combination therapy approaches, which are being investigated in two ongoing phase 4 clinical trials. To ensure relevancy to wider patient populations, understanding and mitigating barriers to recruitment and enrollment early in study development are crucial. Here, we describe the findings of a unique approach in IBD research to proactively engage patients in study design and in the development of accessible patient-facing materials.</p><p><strong>Methods: </strong>EXPLORER 2.0 (NCT06045754) and ExiGem (NCT06095128) are phase 4, open-label trials evaluating the efficacy and safety of combination therapy with vedolizumab and either adalimumab or ustekinumab in patients with moderate to severe Crohn's disease (CD), and vedolizumab and tofacitinib in patients with moderate to severe ulcerative colitis (UC). During protocol development, 90-minute interviews were conducted with individuals with CD or UC to gain qualitative insights into patient perceptions on the study design and informed consent forms (ICFs). Interview participants were members of Inspire, a global online health community platform, and not aware of the study sponsor.</p><p><strong>Results: </strong>Overall, participants found the concept of achieving remission with combination therapy appealing, although they expressed concerns about its safety. Other concerns included the stringent eligibility criteria and the number of clinic visits and procedures involved in the trials. Participants were generally positive about the inclusion of patient-reported outcomes. Participants suggested the use of clearer language in patient materials, including ICFs, and the inclusion of a visual dosing timeline to clarify treatment schedules. Using the participants' feedback, the study protocols and ICFs have been amended.</p><p><strong>Conclusion: </strong>These interview findings directly informed patient-centric modifications to trial protocols and patient-facing materials for the EXPLORER 2.0 and ExiGem trials with the essential goal of improving patient diversity and recruitment, which have been suboptimal in IBD research.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"603005"},"PeriodicalIF":2.6,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13508045/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148825668","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
Metabolic Dysfunction-Associated Steatotic Liver Disease: Clinical Heterogeneity, Risk Stratification, and Personalized Care. 代谢功能障碍相关的脂肪变性肝病:临床异质性、风险分层和个性化护理
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-08-17 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S618553
Thong Duy Vo
{"title":"Metabolic Dysfunction-Associated Steatotic Liver Disease: Clinical Heterogeneity, Risk Stratification, and Personalized Care.","authors":"Thong Duy Vo","doi":"10.2147/CEG.S618553","DOIUrl":"10.2147/CEG.S618553","url":null,"abstract":"<p><p>Metabolic dysfunction-associated steatotic liver disease (MASLD) has emerged as the most prevalent chronic liver disease worldwide, reflecting the global epidemic of obesity, type 2 diabetes, and metabolic syndrome. However, MASLD is not a homogeneous condition; rather, it encompasses a broad clinical and biological spectrum ranging from simple steatosis to progressive steatohepatitis, advanced fibrosis, cirrhosis, and hepatocellular carcinoma. This heterogeneity is driven by complex interactions between metabolic dysfunction, genetic susceptibility, environmental exposures, and extrahepatic comorbidities. Recent advances have shifted the paradigm from a \"one-size-fits-all\" approach toward risk stratification and personalized care. Non-invasive tests (NITs), including FIB-4, transient and shear wave elastography, and novel biomarkers, have enabled scalable fibrosis assessment and prognostic stratification in real-world settings. At the same time, emerging therapies targeting metabolic pathways, inflammation, and fibrosis are paving the way for individualized treatment strategies. This review provides an updated and clinically oriented synthesis of MASLD by integrating clinical heterogeneity, phenotype-based disease trajectories, multidimensional risk stratification, and personalized management into a practical framework for precision hepatology. In addition, we summarize recent therapeutic advances, discuss current controversies and implementation challenges, and highlight future directions toward individualized care.</p>","PeriodicalId":10208,"journal":{"name":"Clinical and Experimental Gastroenterology","volume":"19 ","pages":"618553"},"PeriodicalIF":2.6,"publicationDate":"2026-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13496127/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148788858","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
引用次数: 0
The Metabolic Legacy of Acute Pancreatitis: Post-Pancreatitis Diabetes Mellitus. 急性胰腺炎的代谢遗产:胰腺炎后糖尿病。
IF 2.6
Clinical and Experimental Gastroenterology Pub Date : 2026-08-12 eCollection Date: 2026-01-01 DOI: 10.2147/CEG.S635877
Serge Chooklin, Serhii Chuklin
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