Chronic Kidney Disease (Stages 4 and 5), Peritoneal Dialysis (PD)
Conditions
Keywords
Synbiotics, Probiotics, Prebiotics, Inflammation, Uremic Toxins, Dialysis
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
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic
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.
DIETARY_SUPPLEMENTPlacebo
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.
Sponsors
Hospital Universitario Dr. Jose E. Gonzalez
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in serum high-sensitivity C-reactive protein (hs-CRP) at 3 and 6 months. | Baseline (Month 0), Month 3, and Month 6. | 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. |
| Change from baseline in Erythrocyte Sedimentation Rate (ESR) at 3 and 6 months. | Baseline (Month 0), Month 3, and Month 6. | 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. |
| Change from baseline in serum p-Cresyl Sulfate (pCS) levels at 3 and 6 months. | Baseline (Month 0), Month 3, and Month 6. | 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. |
| Change from baseline in serum Indoxyl Sulfate (IS) levels at 3 and 6 months. | Baseline (Month 0), Month 3, and Month 6. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Malnutrition-Inflammation Score (MIS) at 3 and 6 months. | Baseline (Month 0), Month 3, and Month 6. | 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. |
| Number of peritonitis episodes during the 6-month follow-up period. | Up to 6 months. | 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. |
Countries
Mexico
Contacts
CONTACTElisa María Guadalupe Guerrero González, MD
CONTACTGiovanna Yazmín Arteaga Müller, MD, PhD
PRINCIPAL_INVESTIGATORElisa María Guadalupe Guerrero González, MD
Hospital Universitario. Dr. José Eleuterio González
Outcome results
None listed