NCT01781312Unknown不适用
Proof-of-concept Study of Efficacy and Safety of Dietary Supplementation With Probiotics in IgAN Patients
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Change in albuminuria
研究概览
简要总结
Recent studies have shown an increased gastrointestinal reactivity and increased intestinal permeability in IgA nephropathy (IgAN). Probiotic supplementation is known to impact the gastrointestinal immune system possibly by improvement of both the immunologic and the non-immunologic intestinal barrier. Probiotic supplementation should thus theoretically have an effect on IgAN. In this study the investigators will study the efficacy and safety of Lactobacillus reuteri.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Above 18 years
- •Primary IgAN, verified by biopsy
- •Albuminuria > 0.75 g/24 h (verified by at least four sample results within a two years period prior to inclusion)
- •Serum creatinine less than 200 umol/L (verified by at least four sample results within a two years period prior to inclusion)
- •Having signed informed consent form
排除标准
- •Participation in another clinical intervention trial
- •Patients with celiac disease
- •Patients with secondary IgAN
- •Creatinine clearance below 30 ml/min (mean of 3 measurements)
- •Introduction of an ACE inhibitor or angiotensin II receptor blocker during the last three months prior to inclusion
- •Patients treated with immunosuppressive or systemic corticosteroid drugs within the last twelve months
- •Patients using probiotic products within the last three months (includes probiotic milk products)
- •Known allergy or intolerance to any of the ingredients in the probiotic product
结局指标
主要结局
Change in albuminuria
时间窗: Baseline and 3 months
次要结局
- Change in renal function(Baseline and 3 months)
- Change in IgA/IgG immune complexes(Baseline and 3 months)
- Change in hematuria(Baseline and 3 months)
- Change in immunological markers in blood(Baseline and 3 months)
- Change in IBS (irritable bowel syndrome) symptoms(Baseline and 3 months)
研究者
Hilde Kloster Smerud
Clinical Research Scientist
Uppsala University Hospital
研究点 (3)
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