NCT05071131招募中不适用
Investigating the Effect of Inulin on Gut Microbiota and Gut Barrier in Advanced Chronic Kidney Disease - a Randomised, Placebo-controlled Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Plasma concentration of Zonulin-1
研究概览
简要总结
An adequate fiber intake is crucial for a well-balanced diet and reduces the risk of chronic diseases. However, nutritional recommendations for chronic kidney disease patients lead to an insufficient fiber intake with possible maladaptive effects on the gut microbiome. Therefore, we want to study the effects of a 35-day inulin supplementation on the gut microbiome, gut barrier function, bacterial metabolites and immune cell states in chronic kidney disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women in a ratio of 1:1
- •Age 18-75 years
- •Body mass index 25.0 - 39.9 kg/m^2
- •End-stage kidney disease, which has been treated regularly with hemodialysis for at least 3 months
排除标准
- •Malignant diseases
- •Recent or current hospitalization
- •Postoperative phase
- •Acute infections
- •Malnutrition
- •Antibiotic treatment within the last 4 weeks
- •Regular intake of probiotics and/or prebiotics
- •Change of body weight of more than 2 kg in the month prior to study entry
- •Known drug or alcohol abuse
- •Changes applied in July 2022 according to amendment no. 1:
- •Two inclusion criteria were changed to improve recruitment
- •Age range was changed from 18-70 to 18-75 years
- •BMI range was changed from 18.5 - 34.9 to 25.0 - 39.9 kg/m^2
- •The intervention scheme was adapted to increase patient adherence
- •A 7-day adaption phase with half of the dose (15 grams per day) at the start of the intervention was introduced, changing treatment duration from 28 to 35 days
- •Changes applied in January 2024 according to amendment no. 2:
- •One inclusion criteria was changed to improve recruitment
- •BMI range was changed from 25 - 39,9 to 18,5 - 39,9 kg/m²
- •Last visit was brought foward by 4 weeks.
结局指标
主要结局
Plasma concentration of Zonulin-1
时间窗: After 35 days compared to placebo
Measured by ELISA \[ng/ml\]
次要结局
- Plasma concentration of IL-6(After 35 days compared to placebo)
- Cystatin c(After 35 days compared to placebo)
- Short-chain fatty acid-associated bacterial gene expression(After 35 days compared to placebo and adjusted for baseline)
- Serum concentration of Trimethylamine-N-Oxide (TMAO)(After 35 days compared to placebo)
- Creatinine(After 35 days compared to placebo)
- Plasma concentration of soluble CD14(After 35 days compared to placebo)
- Short-chain fatty acid-associated gene expression in immune cells(After 35 days compared to placebo)
- Indole-associated bacterial gene expression(After 35 days compared to placebo)
- Creatinine / cystatin c ratio(After 35 days compared to placebo)
- Fecal microbiome taxonomy(After 35 days compared to placebo)
- Fecal metabolome(After 35 days compared to placebo and adjusted for baseline)
- Frequency of circulating T-cell subtypes(After 35 days compared to placebo)
- Plasma concentration of IL-1(After 35 days compared to placebo)
- Plasma concentration of TNF-alpha(After 35 days compared to placebo)
- Indole-associated gene expression in immune cells(After 35 days compared to placebo)
- Serum metabolome(After 35 days compared to placebo)
- Activation potential of aryl hydrocarbon receptor (AhR) in serum(After 35 days compared to placebo and adjusted for baseline)
- Office systolic blood pressure(After 35 days compared to placebo)
- Office diastolic blood pressure(After 35 days compared to placebo)
研究者
Till Schütte
Principle Investigator
Charite University, Berlin, Germany
研究点 (2)
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