The INHABIT (synergIstic effect of aNtHocyAnin and proBIoTics in) Inflammatory Bowel Disease trial: a study protocol for a double-blind, randomised, controlled, multi-arm trial

IF 2.4 Q3 NUTRITION & DIETETICS Journal of Nutritional Science Pub Date : 2024-01-08 DOI:10.1017/jns.2023.113
D. Cosier, Kelly Lambert, M. Batterham, Martina Sanderson-Smith, Kylie J Mansfield, Karen Charlton
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Abstract

Abstract Ulcerative Colitis (UC), a type of Inflammatory Bowel Disease (IBD), is a chronic, relapsing gastrointestinal condition with increasing global prevalence. The gut microbiome profile of people living with UC differs from healthy controls and this may play a role in the pathogenesis and clinical management of UC. Probiotics have been shown to induce remission in UC; however, their impact on the gut microbiome and inflammation is less clear. Anthocyanins, a flavonoid subclass, have shown anti-inflammatory and microbiota-modulating properties; however, this evidence is largely preclinical. To explore the combined effect and clinical significance of anthocyanins and a multi-strain probiotic, a 3-month randomised controlled trial will be conducted in 100 adults with UC. Participants will be randomly assigned to one of four groups: anthocyanins (blackcurrant powder) + placebo probiotic, probiotic + placebo fruit powder, anthocyanin + probiotic, or double placebo. The primary outcome is a clinically significant change in the health-related quality-of-life measured with the Inflammatory Bowel Disease Questionnaire-32. Secondary outcomes include shotgun metagenomic sequencing of the faecal microbiota, faecal calprotectin, symptom severity, and mood and cognitive tests. This research will identify the role of adjuvant anti-inflammatory dietary treatments in adults with UC and elucidate the relationship between the gut microbiome and inflammatory biomarkers in this disease, to help identify targeted individualised microbial therapies. ANZCTR registration ACTRN12623000630617.
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炎症性肠病 INHABIT(阿托品和促进剂的协同作用)试验:双盲、随机、对照、多臂试验的研究方案
摘要 溃疡性结肠炎(UC)是炎症性肠病(IBD)的一种,是一种慢性、复发性胃肠道疾病,在全球的发病率越来越高。UC 患者的肠道微生物群谱与健康对照组不同,这可能在 UC 的发病机制和临床治疗中发挥作用。事实证明,益生菌可诱导 UC 病症缓解;然而,益生菌对肠道微生物组和炎症的影响尚不明确。花青素是一种类黄酮亚类,具有抗炎和调节微生物群的特性;然而,这些证据主要是临床前的。为了探索花青素和多菌株益生菌的综合效果和临床意义,我们将在 100 名患有 UC 的成人中开展一项为期 3 个月的随机对照试验。参与者将被随机分配到四组中的一组:花青素(黑加仑粉)+安慰剂益生菌组、益生菌+安慰剂果粉组、花青素+益生菌组或双安慰剂组。主要研究结果是通过炎症性肠病问卷-32测量与健康相关的生活质量是否有临床显著变化。次要结果包括粪便微生物群的猎枪元基因组测序、粪便热保护蛋白、症状严重程度以及情绪和认知测试。这项研究将确定辅助抗炎饮食疗法在成人UC患者中的作用,并阐明肠道微生物群与该疾病的炎症生物标志物之间的关系,从而帮助确定有针对性的个体化微生物疗法。ANZCTR 注册 ACTRN12623000630617。
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来源期刊
Journal of Nutritional Science
Journal of Nutritional Science NUTRITION & DIETETICS-
CiteScore
3.00
自引率
0.00%
发文量
91
审稿时长
7 weeks
期刊介绍: Journal of Nutritional Science is an international, peer-reviewed, online only, open access journal that welcomes high-quality research articles in all aspects of nutrition. The underlying aim of all work should be, as far as possible, to develop nutritional concepts. JNS encompasses the full spectrum of nutritional science including public health nutrition, epidemiology, dietary surveys, nutritional requirements, metabolic studies, body composition, energetics, appetite, obesity, ageing, endocrinology, immunology, neuroscience, microbiology, genetics, molecular and cellular biology and nutrigenomics. JNS welcomes Primary Research Papers, Brief Reports, Review Articles, Systematic Reviews, Workshop Reports, Letters to the Editor and Obituaries.
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