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

Study Overview

• Status: Recruiting
• Conditions: Peritoneal Dialysis (PD); Chronic Kidney Disease (Stages 4 and 5)
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Synbiotic

Detailed Description

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:

1. 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.
2. 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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisa María Guadalupe Guerrero González, MD; Phone Number: 528182803788; Email: eguerrerog@uanl.edu.mx
• Study Contact Backup: Name: Giovanna Yazmín Arteaga Müller, MD, PhD; Phone Number: 528112512168; Email: giomuller@gmail.com

Study Locations

• Mexico
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Recruiting
      • Hospital Universitario Dr. José E. González, Centro Regional de Enfermedades Renales (CRER)
      • Contact: Irma Isabel Flores Ponzio, MD; Phone Number: 528127312940; Email: Irmaflorespz24@gmail.com
      • Contact: Heidi Daniela Hernández Francisco, MD; Phone Number: 528180259573; Email: heididhf@gmail.com
      • Principal Investigator: Elisa María Guadalupe Guerrero González, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants assigned to this arm will receive one identical, inactive oral capsule daily for a period of 6 months.	Dietary supplement: Placebo; 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.
Experimental: 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.	Dietary supplement: Synbiotic; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months.	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.	Baseline (Month 0), Month 3, and Month 6.
Change from baseline in Erythrocyte Sedimentation Rate (ESR) at 3 and 6 months.	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.	Baseline (Month 0), Month 3, and Month 6.
Change from baseline in serum p-Cresyl Sulfate (pCS) levels at 3 and 6 months.	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.	Baseline (Month 0), Month 3, and Month 6.
Change from baseline in serum Indoxyl Sulfate (IS) levels at 3 and 6 months.	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.	Baseline (Month 0), Month 3, and Month 6.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Malnutrition-Inflammation Score (MIS) at 3 and 6 months.	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.	Baseline (Month 0), Month 3, and Month 6.
Number of peritonitis episodes during the 6-month follow-up period.	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.	Up to 6 months.

Collaborators and Investigators

• Sponsor: Hospital Universitario Dr. Jose E. Gonzalez
• Investigators: Principal Investigator: Elisa María Guadalupe Guerrero González, MD, Hospital Universitario. Dr. José Eleuterio González

Publications and helpful links

General Publications

• 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.

Helpful Links

• Official website of the Kidney Disease: Improving Global Outcomes (KDIGO) organization, providing international clinical practice guidelines for kidney disease.

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: July 4, 2026
• First Submitted That Met QC Criteria: July 4, 2026
• First Posted (Actual): July 10, 2026

Study Record Updates

• Last Update Posted (Actual): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 4, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Inflammation; Probiotics; Dialysis; Prebiotics; Synbiotics; Uremic Toxins
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Inflammation; Renal Insufficiency, Chronic; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Prebiotics; Probiotics; Synbiotics
• Other Study ID Numbers: NF25-00008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: To protect the confidentiality of the participants, individual participant data will not be made publicly available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No