Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients

Hospital Universitario Dr. Jose E. Gonzalez60 enrolled

Overview

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

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

Interventions

SynbioticDIETARY_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.

PlaceboDIETARY_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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

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.