益生纤维对假体关节感染患者肠道微生物群和手术效果的影响(PENGUIN)--随机、双盲、安慰剂对照试验研究方案(ACTRN12623001273673)。

IF 4.4 2区 医学 Q1 NUTRITION & DIETETICS
Deepti K Sharma, Balamurugan Ramadass, Stuart A Callary, Anthony Meade, Rishikesh Dash, Robyn Clothier, Gerald J Atkins, L Bogdan Solomon, Boopalan Ramasamy
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引用次数: 0

摘要

背景:人工关节感染(PJI)是关节置换手术中最具破坏性的并发症,1%-5%的患者会受到感染。尽管严格遵守无菌操作规程并采取预防措施,感染仍是翻修关节置换术最常见的原因,而且感染率还在不断上升。PJI 的治疗极具挑战性,通常需要反复进行大手术,且效果不佳。PJI 的持续发生以及治疗后的持续存在,使人们对当前的治疗模式产生了质疑。临床前证据表明,关节置换术患者肠道健康的改变与 PJI 风险之间存在联系。抗性淀粉能增强有益微生物群并产生短链脂肪酸,有助于恢复肠道生理机能,而短链脂肪酸具有多种有益健康的特性。本研究的主要目的是调查市售益生元纤维配方对计划接受两阶段翻修手术的 PJI 患者肠道微生物群的影响:一项双盲安慰剂对照试验将评估首次接受两期翻修手术的 PJI 患者服用市售益生元补充剂 8 周的效果。补充阶段将从第一阶段翻修手术后开始,80 名患者将被随机分配,每天接受试验产品(34 克抗性淀粉)或安慰剂(吉士粉),为期 8 周。将在基线、第一阶段手术后四周和八周以及第二阶段手术时各采集一次粪便和血液标本。将测量肠道微生物组概况、炎症细胞因子和肠道通透性生物标记物。在第一和第二阶段手术期间,将在术中采集组织标本。基线饮食模式和肠道症状将通过有效问卷进行记录。在第二阶段手术后的一年和两年,将采用德尔菲标准报告两组患者的治疗结果:讨论:这将是第一项调查肠道健康优化与预防关节置换术患者 PJI 复发之间关系的研究。如果补充抗性淀粉能改善肠道健康并减少全身炎症,那么优化肠道微生物组将成为关节置换术患者术前管理的推荐策略。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The effect of prebiotic fibre on the gut microbiome and surgical outcomes in patients with prosthetic joint infection (PENGUIN) - study protocol for a randomised, double-blind, placebo-controlled trial (ACTRN12623001273673).

Background: Prosthetic Joint Infection (PJI) is the most devastating complication of arthroplasty surgery and affects 1-5% of patients. Despite strict adherence to aseptic protocols and preventive measures, infection is the most common reason for revision arthroplasty, and the incidence is increasing. Treatment of PJI is challenging and often requires repeated major surgeries with sequentially poor results. The continued occurrence of PJI, and persistence after treatment, brings into question the current treatment paradigm. Preclinical evidence suggests a link between altered gut health and the risk of PJI in arthroplasty patients. Resistant starches helps to restore gut physiology by enhancing the beneficial microbiome and producing short-chain fatty acids, which have several health-conferring properties. The primary aim of this study is to investigate the effect of a commercially available prebiotic fibre formulation on the gut microbiome in PJI patients planned for a two-stage revision surgery.

Methods: A double-blind placebo-controlled trial will assess the effect of 8-week supplementation of a commercially available prebiotic supplement in patients presenting with first-time PJI undergoing two-stage revision surgery. The supplementation phase will start after the first stage revision, and 80 patients will be randomised to receive either a test product (34 g of resistant starch) or a placebo (custard powder) daily for eight weeks. Stool and blood specimens will be collected at baseline, four weeks and eight weeks after the first-stage surgery and once at second-stage surgery. Gut microbiome profile, inflammatory cytokines and gut permeability biomarkers will be measured. Tissue specimens will be collected intra-operatively during first and second-stage surgeries. Baseline dietary patterns and gut symptoms will be recorded using validated questionnaires. Treatment outcomes will be reported for both cohorts using the Delphi criterion at one and two years after second-stage surgery.

Discussion: This will be the first study to investigate the relationship between gut health optimisation and preventing PJI recurrence in arthroplasty patients. If supplementation with resistant starch improves gut health and reduces systemic inflammation, optimising the gut microbiome will be a recommended preoperative management strategy for arthroplasty patients.

Trial registration no: ACTRN12623001273673.

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来源期刊
Nutrition Journal
Nutrition Journal NUTRITION & DIETETICS-
CiteScore
9.80
自引率
0.00%
发文量
68
审稿时长
4-8 weeks
期刊介绍: Nutrition Journal publishes surveillance, epidemiologic, and intervention research that sheds light on i) influences (e.g., familial, environmental) on eating patterns; ii) associations between eating patterns and health, and iii) strategies to improve eating patterns among populations. The journal also welcomes manuscripts reporting on the psychometric properties (e.g., validity, reliability) and feasibility of methods (e.g., for assessing dietary intake) for human nutrition research. In addition, study protocols for controlled trials and cohort studies, with an emphasis on methods for assessing dietary exposures and outcomes as well as intervention components, will be considered. Manuscripts that consider eating patterns holistically, as opposed to solely reductionist approaches that focus on specific dietary components in isolation, are encouraged. Also encouraged are papers that take a holistic or systems perspective in attempting to understand possible compensatory and differential effects of nutrition interventions. The journal does not consider animal studies. In addition to the influence of eating patterns for human health, we also invite research providing insights into the environmental sustainability of dietary practices. Again, a holistic perspective is encouraged, for example, through the consideration of how eating patterns might maximize both human and planetary health.
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