Impact of Synbiotic Supplementation in Peritoneal Dialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months.
研究概览
简要总结
The goal of this clinical trial is to learn if synbiotics work to lower inflammation in adults with chronic kidney disease who are on peritoneal dialysis. Synbiotics are daily capsules that contain a mix of probiotics (good bacteria) and prebiotics (fiber that feeds good bacteria).
The main questions it aims to answer are:
Do synbiotics lower the level of inflammation markers in the blood? Do synbiotics improve the nutritional status of the participants? Do synbiotics lower the number of peritonitis (peritoneal infections) episodes?
Researchers will compare synbiotics to a placebo to see if the treatment works. A placebo is a look-alike capsule that contains no active ingredients. Participants will:
Take 1 capsule every day for 6 months Visit the clinic at the start, at 3 months, and at 6 months for blood tests and nutrition checkups
详细描述
This is a randomized, controlled, double-blind clinical trial designed to evaluate the clinical and biochemical impact of synbiotic supplementation in patients with chronic kidney disease undergoing peritoneal dialysis at the Regional Center for Kidney Diseases. Eligible participants will be randomly assigned in a 1:1 ratio into one of two parallel groups for a 6-month period:
- Synbiotic Group: Participants will receive one oral capsule daily in the morning before meals, containing prebiotic fibers (chicory inulin root and tapioca starch) and probiotic strains (Bifidobacterium longum, Lactobacillus acidophilus, and Streptococcus thermophilus) at a concentration of 7.5 x 10^12 CFU/100g.
- Placebo Group: Participants will receive one identical, inactive oral capsule daily.
Clinical and biochemical evaluations will be conducted at three distinct time points: Baseline (Visit 1), 3 months (Visit 2), and 6 months (Visit 3). At each visit, blood samples will be drawn to measure primary pro-inflammatory and uremic toxin markers, specifically p-cresol and indoxyl sulfate, alongside high-sensitivity C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Additionally, nutritional status will be evaluated using the Malnutrition-Inflammation Score (MIS). Secondary clinical outcomes, including the incidence of peritonitis episodes, will be documented throughout the entire 6-month study duration. To ensure protocol compliance, participant adherence will be tracked using two methods: Pill-counts conducted during each scheduled follow-up visit and periodic telephone calls between visits to provide reminders and monitor supplement intake.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
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
- •Patients aged 18 years or older.
- •Patients diagnosed with kidney disease who have been receiving peritoneal dialysis at home for at least 1 month.
排除标准
- •Patients who are unable to eat or receive food through a feeding tube.
- •Patients who have taken prebiotics or probiotics (supplements that support gut health) in the month before the study starts.
- •Patients who used antibiotics in the month before the study starts.
- •Patients who cannot attend the scheduled follow-up visits (missing the second follow-up appointment will result in being removed from the study).
- •Note on non-adherence and withdrawal: Patients who are unable to take their assigned capsules regularly (taking less than 80% of the total capsules will result in being removed from the study).
结局指标
主要结局
Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months.
时间窗: Baseline (Month 0), Month 3, and Month 6.
Serum hs-CRP levels will be measured to evaluate systemic inflammation. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Change from baseline in Erythrocyte Sedimentation Rate (ESR) at 3 and 6 months.
时间窗: Baseline (Month 0), Month 3, and Month 6.
Erythrocyte Sedimentation Rate (ESR) will be measured to evaluate systemic inflammation. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Change from baseline in serum p-Cresyl Sulfate (pCS) levels at 3 and 6 months.
时间窗: Baseline (Month 0), Month 3, and Month 6.
Serum levels of the microbiota-derived uremic toxin p-Cresyl Sulfate will be quantified to evaluate the effect of the synbiotic intervention over time. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
Change from baseline in serum Indoxyl Sulfate (IS) levels at 3 and 6 months.
时间窗: Baseline (Month 0), Month 3, and Month 6.
Serum levels of Indoxyl Sulfate will be quantified as a key protein-bound uremic toxin to determine if the synbiotic intervention decreases its accumulation. The change will be assessed by comparing values at 3 and 6 months against the baseline values.
次要结局
- Change from baseline in Malnutrition-Inflammation Score (MIS) at 3 and 6 months.(Baseline (Month 0), Month 3, and Month 6.)
- Number of peritonitis episodes during the 6-month follow-up period.(Up to 6 months.)
研究者
Irma Isabel Flores Ponzio
Clinical Research Fellow, Department of Nephrology
Hospital Universitario Dr. Jose E. Gonzalez