The Impact of CKD on Uremic Toxins and Gut Microbiota.
Jacek Rysz, Beata Franczyk, Janusz Ławiński...
https://pubmed.ncbi.nlm.nih.gov/33807343/Actively Recruiting
Led by Hospital Universitario Dr. Jose E. Gonzalez · Updated on 2026-07-10
60
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating whether synbiotics, a combination of probiotics and prebiotics, can reduce inflammation and improve nutrition in adults with chronic kidney disease who are undergoing peritoneal dialysis. This randomized, controlled, double-blind trial compares synbiotic capsules to placebo capsules to see if they lower inflammation markers in the blood, improve nutritional status, and reduce peritonitis episodes. Participants are randomly assigned to receive either a daily synbiotic capsule containing specific probiotic strains and prebiotic fibers or a daily placebo capsule with no active ingredients. This treatment lasts for 6 months, with capsules taken each morning before meals. The study includes clinical and biochemical assessments at baseline, 3 months, and 6 months, during which blood tests and nutritional evaluations are performed. During the trial, participants visit the clinic three times for blood draws and nutrition checkups. Researchers measure markers like high-sensitivity C-reactive protein, erythrocyte sedimentation rate, p-cresyl sulfate, and indoxyl sulfate to assess inflammation and toxins. Nutritional status is evaluated using the Malnutrition-Inflammation Score, and occurrences of peritonitis are recorded. Adherence is monitored through pill counts and reminder calls. The total participation lasts 6 months.
CONDITIONS
Probiotic and Prebiotic Supplementation in Peritoneal Dialysis Patients
E
Elisa María Guadalupe Guerrero González, MD
G
Giovanna Yazmín Arteaga Müller, MD, PhD
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Hospital Universitario Dr. Jose E. Gonzalez
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 months
Participants take one capsule daily in the morning before meals, receiving either the synbiotic supplement or a placebo for 6 months.
3 clinic visits at baseline, 3 months, and 6 months
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Have more questions? Get in touch with our team for quick support
Jacek Rysz, Beata Franczyk, Janusz Ławiński...
https://pubmed.ncbi.nlm.nih.gov/33807343/Edwina A Brown, Simon J Davies, Peter Rutherford...
https://pubmed.ncbi.nlm.nih.gov/14569106/Yong Jin Lim, Nicole A Sidor, Nicholas C Tonial...
https://pubmed.ncbi.nlm.nih.gov/33668632/Sixiu Liu, Hua Liu, Lei Chen...
https://pubmed.ncbi.nlm.nih.gov/32112136/Alice Sabatino, Giuseppe Regolisti, Carmela Cosola...
https://pubmed.ncbi.nlm.nih.gov/28271466/Ludovico Abenavoli, Emidio Scarpellini, Carmela Colica...
https://pubmed.ncbi.nlm.nih.gov/31703257/Giovanna Yazmín Arteaga-Muller, Samantha Flores-Treviño, Paola Bocanegra-Ibarias...
https://pubmed.ncbi.nlm.nih.gov/38674803/Na Tian, Lu Li, Jack Kit-Chung Ng...
https://pubmed.ncbi.nlm.nih.gov/36235699/Grégoire Wieërs, Leila Belkhir, Raphaël Enaud...
https://pubmed.ncbi.nlm.nih.gov/32010640/Maria Claudia Cruz Andreoli, Claudia Totoli
https://pubmed.ncbi.nlm.nih.gov/31939534/Hospital Universitario Dr. Jose E. Gonzalez
Lead Sponsor