Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients

NCT07694791 | Recruiting

• 1 other identifier: NF25-00008
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Peritoneal Dialysis (PD); Chronic Kidney Disease (Stages 4 and 5)

Keywords

Synbiotics; Probiotics; Prebiotics; Inflammation; Uremic Toxins; Dialysis

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (2)

• 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.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Participants assigned to this arm will receive one identical, inactive oral capsule daily for a period of 6 months.

Dietary Supplement: Placebo

Synbiotic

EXPERIMENTAL

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

Interventions

Synbiotic DIETARY_SUPPLEMENT

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.

Synbiotic

Placebo DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 18 years or older.
• Patients diagnosed with kidney disease who have been receiving peritoneal dialysis at home for at least 1 month.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Universitario Dr. Jose E. Gonzalez: lead

Study Sites (1)

Hospital Universitario Dr. José E. González, Centro Regional de Enfermedades Renales (CRER)

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

Related Publications (10)

• 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.

  PMID: 14569106 BACKGROUND

• 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.

  PMID: 32112136 BACKGROUND

• 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.

  PMID: 28271466 BACKGROUND

• 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.

  PMID: 38674803 BACKGROUND

• 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.

  PMID: 36235699 BACKGROUND

• 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.

  PMID: 33668632 BACKGROUND

• 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.

  PMID: 31939534 BACKGROUND

• 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.

  PMID: 32010640 BACKGROUND

• 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.

  PMID: 33807343 BACKGROUND

• 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.

  PMID: 31703257 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Inflammation

Interventions

Synbiotics

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Study Officials

• Elisa María Guadalupe Guerrero González, MD

  Hospital Universitario. Dr. José Eleuterio González

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisa María Guadalupe Guerrero González, MD

CONTACT

528182803788; eguerrerog@uanl.edu.mx

Giovanna Yazmín Arteaga Müller, MD, PhD

CONTACT

528112512168; giomuller@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Fellow, Department of Nephrology

Model Details: Participants will be recruited using a consecutive sampling method during their regular outpatient visits at the Regional Center for Kidney Diseases. Due to this rolling enrollment strategy, participants will enter the study and initiate their 6-month follow-up period at different times, based on when they meet eligibility criteria and provide informed consent

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: October 3, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)