An interventional study of Synbiotic and Placebo in Chronic Kidney Disease (Stages 4 and 5) and Peritoneal Dialysis (PD), sponsored by Hospital Universitario Dr. Jose E. Gonzalez. Recruiting at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Hospital Universitario Dr. Jose E. Gonzalez · Not applicable, Interventional, and Supportive care
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:
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.
3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.
This study's planned enrollment of 60 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.
Browse Renal Insufficiency, Chronic studies →Hospital Universitario Dr. Jose E. Gonzalez is the lead sponsor of 83 studies on the registry; 12 are open to participants now.
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Exclusion Criteria:
Participants assigned to this arm will receive one identical, inactive oral capsule daily for a period of 6 months.
Dietary Supplement: Placebo
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Month 0), Month 3, and Month 6.
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.
Time frame: 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.
Time frame: Up to 6 months.
Plan to share: No — To protect the confidentiality of the participants, individual participant data will not be made publicly available.
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Hospital Universitario Dr. Jose E. Gonzalez