A Single-Arm Open-Label Feasibility Study of Probiotics for the Modulation of the Gut Microbiome in IgA Nephropathy (Pro-IgAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Change in levels of IgA1 O-glycosylation at Month 3 compared to baseline.
研究概览
简要总结
IgA nephropathy (IgAN) occurs when a specific form of the IgA antibody lodges on the kidneys and causes damage, which may lead to kidney failure. This form of IgA is likely to come from the gut and the upper airways.
Recent studies have shown that the bacteria that live in these areas may be different in IgAN. We think that the interaction between these and the immune system triggers production of the IgA that leads to kidney damage. We will examine these bacteria in detail, and test whether a probiotic can alter this favorably, and reduce harmful forms of IgA production in IgAN.
详细描述
The purpose of this proposal is to conduct a proof of concept study, to test the hypothesis that dysbiosis of the gut microbiota plays a critical role in the development of IgAN.
Objectives are firstly, to characterise the gut microbiome, and faecal, plasma and urine metabolome, in relation to biomarkers of mucosal immunity and glomerular disease in patients with IgAN. Secondly, Investigators will test whether a multi-strain probiotic (Bio-Kult Advanced) produces a modulatory effect on these indices. The probiotic has been selected with our industry collaborator Protexin, based on previous studies demonstrating reduced faecal microbial diversity in patients with progressive IgAN, compared to those with non-progressive IgAN and healthy subjects.
This study will further our understanding of the interplay between the gut microbiome, metabolome, and mucosal immune system in IgAN. Investigators will generate important pilot data, to inform the design of a longer-term randomised clinical trial of probiotics in IgAN, and to identify potential plasma biomarkers to highlight those at risk of progressive disease, and those who may respond to treatments targeted to the gut.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy-proven IgAN
- •Age 18 years or older
- •Able and willing to give informed consent
- •Sufficient understanding of English to understand the patient information sheet and complete questionnaires
- •No change in medications for 6 weeks up to the Baseline visit
- •Stable diet (e.g. not a change to elimination, reduction, vegan or vegetarian diet) for 30-days prior to the baseline visit and during the study
排除标准
- •Aged <18 years
- •Unable or unwilling to give informed consent
- •eGFR < 45 ml/min/1.73 m2 (measured by CKD-EPI formula)
- •Already taking a regular pre- or pro-biotic supplement or other dietary supplement aimed at modulating the gut microbiota, within the previous 60-days
- •Predicted to change diet during the study
- •Any of the following conditions:
- •Autoimmune disease (e.g. systemic lupus erythematosus) 6.
- •Serious gastro-intestinal illness (including Crohn's disease, ulcerative colitis, chronic liver disease, significant gastrointestinal surgery or cancer, pancreatitis, motility disorder) 6.
- •Diagnosed infectious illness within the previous 30-days
- •Prescribed any of the following medication within the previous 60-days 7.
- •Antibiotics or anti-viral medications 7.
- •Steroids or other immunosuppressive agents
- •Any other condition which in the opinion of the investigator could interfere with the study
- •Enrolled in a clinical trial of an investigational medicinal product
- •Allergy to any component of BioKult Advanced (including milk or soy allergy)
研究组 & 干预措施
Probiotic
Participants will receive the multi-strain probiotic, Bio-Kult Advanced, 2 capsules twice daily between baseline and month 3 visits.
干预措施: Bio-Kult Advanced (Dietary Supplement)
结局指标
主要结局
Change in levels of IgA1 O-glycosylation at Month 3 compared to baseline.
时间窗: 3 months
The primary outcome, change in circulating IgA O-glycans levels between baseline and 3-months, will be analysed.
次要结局
- Urine protein/creatinine ratio (UP/C) over a 6-month period(Up to Month 6)
- eGFR over a 6 month period(Up to Month 6)