Effect of the Synbiotic Probinul-Neutro® on Gastrointestinal Symptoms and Plasma p-Cresol Level in Chronic Renal Failure
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The interest on gastrointestinal (GI) dysfunction in CKD 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 in CKD 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
      CKD. In the present paper the investigators investigated the effect of a probiotic/prebiotic
      mixture on plasma p-cresol concentrations and GI symptoms and in CKD patients not on dialysis
      yet.
    

Detailed description: 
      In patients with chronic kidney disease (CKD), 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 CKD progression and 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 non-dialyzed CKD
      patients.

      Thirty patients on III-IV CKD stages 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.
    

Intervention name(s): SYNBIOTIC
Intervention type(s): Dietary Supplement
Intervention description(s): INTERVENTION: Probinul neutro® assumed three times a day far from meals as 5 g powder packets dissolved in water. Probinul neutro® contains 5×109 Lactobacillus plantarum, 2×109 Lactobacillus casei subp. rhamnosus and 2×109 Lactobacillus gasseri, 1×109 Bifidobacterium infantis and 1×109 Bifidobacterium longum, 1×109 Lactobacillus acidophilus, 1×109 Lactobacillus salivarus and 1×109 Lactobacillus sporogenes and 5×109 Streptococcus termophilus, prebiotic inulin (2.2 g; VB Beneo Synergy 1) and 1.3 g of tapioca-resistant starch.
PLACEBO: Tapioca-resistant starch powder similar in colour, texture and taste to the symbiotic mixture, assumed three times a day far from meals as 5 g powder packets dissolved in water.
Other intervention name(s): Probinul-Neutro® or PLACEBO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic kidney disease; p-cresol; synbiotic