Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Universitario Dr. Jose E. Gonzalez
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients aged 18 years or older.
Patients diagnosed with kidney disease who have been receiving peritoneal dialysis at home for at least 1 month.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Synbiotic
Dietary supplementOral 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.
Placebo
Dietary supplementOral 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.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: PlaceboPlacebo comparator 1 intervention
Group B: SynbioticExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 6.2
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 6.3
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 6.4
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.Secondary outcomes
1
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 6.2
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov