A pilot randomized control trial to assess the adjunctive effect of diet on response to advanced therapies in patients with UC.

IF 11.6 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
O M Damas, M Leo, N Colina, M Mijares, I Fernandez, J McALeavy, I Hernandez, C Assumpcao, L Garces, M A Quintero, M Ortega, N Solis, C Batista, B De La Torre, M T Abreu, A R Deshpande, D Kerman, Proksell S, Y Ban
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引用次数: 0

Abstract

Diet may influence ulcerative colitis (UC), but its impact on medication response remains unclear. We examined whether two 5-day cycles of a low-calorie, plant-based fasting-mimicking diet (LC-PB) could improve UC response to medications in a controlled trial.

Methods: Adults with active UC starting advanced therapies were randomized to LC-PB + therapy or control diet + therapy. The LC-PB diet provided 1,090 kcal on day one and 725 kcal on days 2-5. SCCAI was assessed at baseline and week 8. The study, planned for 60 patients, ended early due to COVID-19. The primary endpoint was clinical response (week 8, SCCAI decrease ≥ 3). Secondary outcomes were clinical improvement (change in SCCAI from baseline), steroid tapering, C-reactive protein (CRP), serum amyloid A (SAA), and FC (FC).

Results: Of 32 enrolled patients, 23 completed the study. In ITT, 57% in the LC-PB arm (8/14) achieved clinical response by week 8 vs. 35% in controls (6/17, p = 0.11). Secondary analyses indicated greater clinical improvement, measured as continuous SCCAI, in the LC-PB compared to control group (p = .039). The LC-PB group had better SCCAI sub-scores (i.e. urgency, well-being), reductions in SAA and were tapered off steroids compared to controls. Mean CRP and FC decreased more on the LC-PB, but results were not significant. There were no serious adverse events relating to the diet and no weight loss.

Conclusion: The LC-PB diet did not improve clinical response to medications. However, it led to clinical improvement, steroid tapering, and reduced SAA. As results were limited by sample size, larger studies are needed.

一项评估饮食对UC患者对先进治疗反应的辅助作用的先导随机对照试验。
饮食可能影响溃疡性结肠炎(UC),但其对药物反应的影响尚不清楚。在一项对照试验中,我们研究了两个5天周期的低热量、植物性模拟禁食饮食(LC-PB)是否可以改善UC对药物的反应。方法:开始高级治疗的活动性UC成人随机分为LC-PB +治疗或对照饮食+治疗。LC-PB日粮在第1天提供1,090千卡,在第2-5天提供725千卡。在基线和第8周评估SCCAI。该研究计划对60名患者进行研究,但由于COVID-19而提前结束。主要终点是临床反应(第8周,SCCAI下降≥3)。次要结果是临床改善(SCCAI与基线相比的变化)、类固醇逐渐减少、c反应蛋白(CRP)、血清淀粉样蛋白A (SAA)和FC (FC)。结果:32例入组患者中,23例完成了研究。在ITT中,57%的LC-PB组(8/14)在第8周达到临床缓解,而对照组为35% (6/17,p = 0.11)。二级分析显示LC-PB组与对照组相比有更大的临床改善(以连续SCCAI衡量)(p = 0.039)。LC-PB组有更好的SCCAI分(即紧迫感,幸福感),SAA减少,与对照组相比类固醇逐渐减少。LC-PB组平均CRP和FC降低较多,但结果不显著。没有与饮食有关的严重不良事件,也没有体重减轻。结论:LC-PB饮食不能改善临床药物反应。然而,它导致临床改善,类固醇逐渐减少,SAA降低。由于结果受到样本量的限制,需要进行更大规模的研究。
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来源期刊
CiteScore
16.90
自引率
4.80%
发文量
903
审稿时长
22 days
期刊介绍: Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion. As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.
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