Effect of the Synbiotic Probinul-Neutro® on Gastrointestinal Symptoms and Plasma p-Cresol Level in Chronic Renal Failure

Phase 4

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Dietary Supplement: SYNBIOTIC

• Registration Number: NCT02008331
• Lead Sponsor: Federico II University

Brief 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.

Study Timeline

• Study Start: 2013-04
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-12
• Study First Submitted: 2013-12-02
• Study First Submitted QC: 2013-12-06
• Last Update Submitted: 2013-12-06
• Study First Posted: 2013-12-11
• Last Update Posted: 2013-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• age >18 years
• eGFR between 20 and 60 mL/min (stage 3-4 CKD, according to the K/DOQI CKD classification)

Exclusion Criteria

• severe infections
• diabetes
• malignancy
• history of food intolerance
• autoimmune disorders
• severe malnutrition
• clinical conditions requiring artificial feeding
• kidney transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYNBIOTIC	SYNBIOTIC	Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 days

Primary Outcome Measures

Name	Time	Method
Changes in plasma p-cresol concentration	30 days	Fasting blood samples were drawn for the p-cresol plasma level

Secondary Outcome Measures

Name	Time	Method
composite outcome of gastrointestinal symptoms	30 days	Patients were asked to fill in a form for the scored evaluation of gastrointestinal symptoms (upper and inferior abdominal pain, borborygmus and flatus defecation frequency or easeand stool), and stool shape (Bristol stool chart)

Trial Locations

Locations (1)

Federico II University of Naples; 🇮🇹 Naples, Italy