Hemodialysis Clinical Trial
The interest on gastrointestinal (GI) dysfunction in hemodialysis has been growing in the last years. it is now accepted that GI dysfunction in dialyzed patients may contribute to systemic microinflammation by promoting gut dysbiosis and bacterial translocation in the blood. Another mechanism by which GI dysfunction contributes to systemic symptoms is related to metabolic activity of the dysbiotic microflora growing in the gut of these patients to generate toxic compounds such as phenols, indoles, and amines. Epidemiological evidence has strongly linked one of these compounds, p-Cresol, to cardiovascular risk and mortality in hemodialysis patients. In the present paper the investigators investigated the effect of a probiotic/prebiotic mixture on plasma p-cresol concentrations and GI symptoms and in hemodialysis patients.
In patients with end stage renal disease, alterations in gut microbioma are posited to be
responsible for gastrointestinal symptoms and generation of p-cresol, a uremic toxin, that
has been associated to cardiovascular mortality.
This double blind randomized placebo controlled pilot study evaluates whether
Probinul-neutro®, a synbiotic preparation that normalizes intestinal microflora, may lower
plasma p-cresol concentrations and reduce gastrointestinal symptoms in hemodialysis
patients.
Thirty patients on hemodialysis were randomized to receive either Probinul neutro® or
placebo for four weeks. Total plasma p-cresol concentrations was assessed at baseline, and
15 and 30 days after treatment start. At the same study times, ease and frequency of
defecation, upper and lower abdominal pain, stool shape, borborygmi and flatus were
quantified by subjective assessment questionnaires.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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