Synbiotic Supplementation and Inflammation in Predialysis Chronic Kidney Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorCentenario Hospital Miguel Hidalgo
About this trial
Chronic kidney disease (CKD) is a long-term condition in which the kidneys gradually lose their ability to function properly. People with chronic kidney disease (CKD) often experience chronic inflammation and digestive symptoms that may affect their quality of life.
This study aims to evaluate whether daily supplementation with a synbiotic (a combination of probiotics and prebiotics) can reduce inflammation and improve gastrointestinal symptoms in adults with chronic kidney disease (CKD) stages 3 to 5 who are not receiving dialysis.
Participants will be randomly assigned to receive either a synbiotic containing Lactobacillus rhamnosus, Bifidobacterium longum, and agave fructans, or a placebo, for a total of 16 weeks. Blood tests will be performed to measure inflammation, and participants will complete questionnaires related to digestive symptoms, quality of life, and dietary habits.
The information obtained from this study may help improve nutritional strategies and supportive care for people living with chronic kidney disease.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged 18 to 80 years.
Diagnosis of chronic kidney disease in pre-dialysis stages.
Stable clinical condition for at least 3 months prior to enrollment.
Ability to provide written informed consent.
Disqualifiers
Current renal replacement therapy (hemodialysis or peritoneal dialysis).
Acute kidney injury.
Use of antibiotics, probiotics, prebiotics, or synbiotics within 4 weeks prior to enrollment.
Active infection, inflammatory disease, or malignancy.
Trial design
Design model
Parallel
Treatments tested in this trial
Synbiotic Supplement
Dietary supplementOral synbiotic supplement administered once daily for 16 weeks.
Placebo
Other interventionPlacebo identical in appearance, taste, and administration to the synbiotic supplement, administered once daily for 16 weeks.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Synbiotic GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Change in High-Sensitivity C-Reactive Protein (hs-CRP)
Change in serum high-sensitivity C-reactive protein (hs-CRP), measured in mg/L, comparing baseline and 16 weeks between the synbiotic and placebo groups.
Time frame
Baseline and at 16 weeksLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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