Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients
Impact of Synbiotic Supplementation in Peritoneal Dialysis Patients
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
研究概览
详细说明
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.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Elisa María Guadalupe Guerrero González, MD
- 电话号码：528182803788
- 邮箱：eguerrerog@uanl.edu.mx
研究联系人备份
- 姓名：Giovanna Yazmín Arteaga Müller, MD, PhD
- 电话号码：528112512168
- 邮箱：giomuller@gmail.com
学习地点
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Nuevo León
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Monterrey、Nuevo León、墨西哥、64460
- 招聘中
- Hospital Universitario Dr. José E. González, Centro Regional de Enfermedades Renales (CRER)
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接触：
- Irma Isabel Flores Ponzio, MD
- 电话号码：528127312940
- 邮箱：Irmaflorespz24@gmail.com
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接触：
- Heidi Daniela Hernández Francisco, MD
- 电话号码：528180259573
- 邮箱：heididhf@gmail.com
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首席研究员：
- Elisa María Guadalupe Guerrero González, MD
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
- Patients aged 18 years or older.
- Patients diagnosed with kidney disease who have been receiving peritoneal dialysis at home for at least 1 month.
Exclusion Criteria:
- 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).
学习计划
研究是如何设计的？
设计细节
- 主要用途：支持治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
安慰剂比较：Placebo
Participants assigned to this arm will receive one identical, inactive oral capsule daily for a period of 6 months.
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Oral administration of one identical, inactive oral capsule daily taken in the morning before meals for a period of 6 months.
The placebo capsule looks, tastes, and smells exactly like the intervention supplement but contains no active ingredients.
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实验性的：Synbiotic
Participants assigned to this arm will receive one oral capsule daily for a period of 6 months.
Each capsule contains a combination of probiotic strains and prebiotic fibers.
|
Oral administration of an active nutritional supplement consisting of one capsule daily taken in the morning before meals for 6 months.
Each capsule contains a specific synbiotic formulation composed of probiotic strains (Bifidobacterium longum, Lactobacillus acidophilus, and Streptococcus thermophilus at 7.5 x 10^12 CFU/100g) combined with prebiotic soluble fibers (chicory inulin root and tapioca starch) designed to modulate the gut microbiota.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months.
大体时间：Baseline (Month 0), Month 3, and Month 6.
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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.
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Baseline (Month 0), Month 3, and Month 6.
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Change from baseline in Erythrocyte Sedimentation Rate (ESR) at 3 and 6 months.
大体时间：Baseline (Month 0), Month 3, and Month 6.
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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.
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Baseline (Month 0), Month 3, and Month 6.
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Change from baseline in serum p-Cresyl Sulfate (pCS) levels at 3 and 6 months.
大体时间：Baseline (Month 0), Month 3, and Month 6.
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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.
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Baseline (Month 0), Month 3, and Month 6.
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Change from baseline in serum Indoxyl Sulfate (IS) levels at 3 and 6 months.
大体时间：Baseline (Month 0), Month 3, and Month 6.
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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.
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Baseline (Month 0), Month 3, and Month 6.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline in Malnutrition-Inflammation Score (MIS) at 3 and 6 months.
大体时间：Baseline (Month 0), Month 3, and Month 6.
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The Malnutrition-Inflammation Score (MIS) will be used to assess the nutritional and inflammatory status of the patients.
The score ranges from 0 (normal) to 30 (severe malnutrition and inflammation), where a higher score indicates a more severe degree of malnutrition.
The change will be assessed by comparing values at 3 and 6 months against the baseline values.
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Baseline (Month 0), Month 3, and Month 6.
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Number of peritonitis episodes during the 6-month follow-up period.
大体时间：Up to 6 months.
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The total number of confirmed peritonitis episodes per patient will be recorded throughout the study to evaluate if the synbiotic intervention reduces the incidence of infectious complications compared to the placebo group.
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Up to 6 months.
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合作者和调查者
调查人员
- 首席研究员：Elisa María Guadalupe Guerrero González, MD、Hospital Universitario. Dr. José Eleuterio González
出版物和有用的链接
一般刊物
- Tian N, Li L, Ng JK, Li PK. The Potential Benefits and Controversies of Probiotics Use in Patients at Different Stages of Chronic Kidney Disease. Nutrients. 2022 Sep 29;14(19):4044. doi: 10.3390/nu14194044.
- Abenavoli L, Scarpellini E, Colica C, Boccuto L, Salehi B, Sharifi-Rad J, Aiello V, Romano B, De Lorenzo A, Izzo AA, Capasso R. Gut Microbiota and Obesity: A Role for Probiotics. Nutrients. 2019 Nov 7;11(11):2690. doi: 10.3390/nu11112690.
- Lim YJ, Sidor NA, Tonial NC, Che A, Urquhart BL. Uremic Toxins in the Progression of Chronic Kidney Disease and Cardiovascular Disease: Mechanisms and Therapeutic Targets. Toxins (Basel). 2021 Feb 13;13(2):142. doi: 10.3390/toxins13020142.
- Liu S, Liu H, Chen L, Liang SS, Shi K, Meng W, Xue J, He Q, Jiang H. Effect of probiotics on the intestinal microbiota of hemodialysis patients: a randomized trial. Eur J Nutr. 2020 Dec;59(8):3755-3766. doi: 10.1007/s00394-020-02207-2. Epub 2020 Feb 28.
- Brown EA, Davies SJ, Rutherford P, Meeus F, Borras M, Riegel W, Divino Filho JC, Vonesh E, van Bree M; EAPOS Group. Survival of functionally anuric patients on automated peritoneal dialysis: the European APD Outcome Study. J Am Soc Nephrol. 2003 Nov;14(11):2948-57. doi: 10.1097/01.asn.0000092146.67909.e2.
- Sabatino A, Regolisti G, Cosola C, Gesualdo L, Fiaccadori E. Intestinal Microbiota in Type 2 Diabetes and Chronic Kidney Disease. Curr Diab Rep. 2017 Mar;17(3):16. doi: 10.1007/s11892-017-0841-z.
- Arteaga-Muller GY, Flores-Trevino S, Bocanegra-Ibarias P, Robles-Espino D, Garza-Gonzalez E, Fabela-Valdez GC, Camacho-Ortiz A. Changes in the Progression of Chronic Kidney Disease in Patients Undergoing Fecal Microbiota Transplantation. Nutrients. 2024 Apr 10;16(8):1109. doi: 10.3390/nu16081109.
- Andreoli MCC, Totoli C. Peritoneal Dialysis. Rev Assoc Med Bras (1992). 2020 Jan 13;66Suppl 1(Suppl 1):s37-s44. doi: 10.1590/1806-9282.66.S1.37.
- Wieers G, Belkhir L, Enaud R, Leclercq S, Philippart de Foy JM, Dequenne I, de Timary P, Cani PD. How Probiotics Affect the Microbiota. Front Cell Infect Microbiol. 2020 Jan 15;9:454. doi: 10.3389/fcimb.2019.00454. eCollection 2019.
- Rysz J, Franczyk B, Lawinski J, Olszewski R, Cialkowska-Rysz A, Gluba-Brzozka A. The Impact of CKD on Uremic Toxins and Gut Microbiota. Toxins (Basel). 2021 Mar 31;13(4):252. doi: 10.3390/toxins13040252.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- NF25-00008
计划个人参与者数据 (IPD)
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IPD 计划说明
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研究美国 FDA 监管的设备产品
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