Effect of a Synbiotic Containing Lactobacillus Rhamnosus, Bifidobacterium Longum, and Agave Fructans on High-Sensitivity C-Reactive Protein Levels in Patients With Predialysis Chronic Kidney Disease: A Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- Change in High-Sensitivity C-Reactive Protein (hs-CRP)
研究概览
简要总结
Chronic kidney disease (CKD) is a long-term condition in which the kidneys gradually lose their ability to function properly. People with CKD often experience chronic inflammation and digestive symptoms that may affect their quality of life.
This study aims to evaluate whether daily supplementation with a synbiotic (a combination of probiotics and prebiotics) can reduce inflammation and improve gastrointestinal symptoms in adults with CKD stages 3 to 5 who are not receiving dialysis.
Participants will be randomly assigned to receive either a synbiotic containing Lactobacillus rhamnosus, Bifidobacterium longum, and agave fructans, or a placebo, for a total of 16 weeks. Blood tests will be performed to measure inflammation, and participants will complete questionnaires related to digestive symptoms, quality of life, and dietary habits.
The information obtained from this study may help improve nutritional strategies and supportive care for people living with chronic kidney disease.
详细描述
Chronic kidney disease is associated with intestinal dysbiosis, increased intestinal permeability, endotoxemia, and chronic low-grade inflammation, which contribute to cardiovascular risk and reduced quality of life. Alterations in gut microbiota composition are influenced by uremia, dietary restrictions, reduced fiber intake, and medication use.
Synbiotics, which combine probiotics and prebiotics, have shown potential benefits in modulating gut microbiota, strengthening the intestinal barrier, and reducing systemic inflammation. However, evidence in patients with predialysis CKD remains limited.
This randomized, double-blind, parallel, placebo-controlled clinical trial will evaluate the effect of a synbiotic containing Lactobacillus rhamnosus, Bifidobacterium longum, and agave fructans on high-sensitivity C-reactive protein (hs-CRP) levels in adults with CKD stages 3 to 5 not receiving renal replacement therapy.
Participants will be randomly assigned to receive either the synbiotic or a placebo for 16 weeks. Secondary outcomes include gastrointestinal symptoms, kidney function, quality of life, nutritional knowledge, and dietary adherence. All participants will receive standardized nutritional counseling based on KDOQI clinical practice guidelines to ensure consistency between study groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
This is a double-blind study. Participants, care providers, investigators, and outcome assessors will be blinded to group assignment. The synbiotic and placebo will be identical in appearance, packaging, and administration to maintain blinding throughout the study.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 to 80 years.
- •Diagnosis of chronic kidney disease in pre-dialysis stages.
- •Stable clinical condition for at least 3 months prior to enrollment.
- •Ability to provide written informed consent.
排除标准
- •Current renal replacement therapy (hemodialysis or peritoneal dialysis).
- •Acute kidney injury.
- •Use of antibiotics, probiotics, prebiotics, or synbiotics within 4 weeks prior to enrollment.
- •Active infection, inflammatory disease, or malignancy.
- •Pregnancy or breastfeeding
- •Known intolerance or allergy to components of the synbiotic or placebo.
研究组 & 干预措施
Synbiotic Group
Participants assigned to this arm will receive a daily oral synbiotic supplement for a period of 16 weeks.
干预措施: Synbiotic Supplement (Dietary Supplement)
Placebo Group
Participants assigned to this arm will receive a placebo identical in appearance and administration to the synbiotic for 16 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
时间窗: Baseline and at 16 weeks
Change in serum high-sensitivity C-reactive protein (hs-CRP), measured in mg/L, comparing baseline and 16 weeks between the synbiotic and placebo groups.
次要结局
未报告次要终点