Status:
UNKNOWN
Effect of Prebiotics and/or Probiotics on Uremic Toxins and Inflammation Markers in Peritoneal Dialysis Patients
Lead Sponsor:
Unidad de Investigacion Medica en Enfermedades Renales
Collaborating Sponsors:
Centro Universitario de Tonalá
Universidad de Colima
Conditions:
End Stage Renal Failure on Dialysis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
End-stage renal disease (ESRD) is a world public health problem, with high morbidity and mortality. Cardiovascular disease is the main cause of mortality in ESRD; uremic toxin retention and inflammati...
Detailed Description
Objective: The aim of the present study is to evaluate and to compare the effect of a nutritional supplement of probiotics and/or prebiotics on serum concentrations of uremic toxins and inflammatory ...
Eligibility Criteria
Inclusion
- \>3 months on automated peritoneal dialysis treatment
- Signed informed consent
Exclusion
- ESRD of inflammatory cause (lupus, vasculitis, collagenopathies)
- Intake of probiotics, prebiotics or fiber in the last 3 months
- Use of anti-inflammatory drugs or nutritional supplements (immunossuppresants, pentoxifylline, NSAIDs, omega-3)
- Treated with antibiotics or sevelamer
- Treated with research drugs or participants in any clinical trial
- Peritonitis or active infection 2 weeks prior the study
- Any medical condition affecting intestinal absorption (inflammatory bowel disease, short bowel syndrome, bariatric surgery) or severe dysmotility
- Severe malnutrition
- Previous kidney transplantation
- Serious diseases altering the fina outcomes of the study: decompensated heart failure, chronic liver disease, cancer, AIDS.
Key Trial Info
Start Date :
January 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT03770611
Start Date
January 7 2019
End Date
August 1 2020
Last Update
December 10 2018
Active Locations (1)
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1
Umae Hospital de Especialidades
Guadalajara, Jalisco, Mexico, 44290