Effect of Short-term Synbiotic Treatment on Plasma P-cresol Levels in Hemodialysis Patients

Hemodialysis Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02311868
• Other study ID #: P-cres Probinul
• Status: Recruiting
• Phase: Phase 4
• First received: December 4, 2014
• Last updated: December 8, 2014
• Start date: December 2014
• Est. completion date: February 2015

Study information

• Verified date: December 2014
• Source: Federico II University
• Contact: eleonora riccio
• Phone: 3396770124
• Email: elyriccio[@]libero.it
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• hemodialysis

• age >18 years

Exclusion Criteria:

• severe infections

• diabetes

• malignancy

• history of food intolerance

• autoimmune disorders

• severe malnutrition

• clinical conditions requiring artificial feeding

• kidney transplant

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis

Intervention

Dietary Supplement:
• SYNBIOTIC (Probinul neutro®)
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.

Locations

Country	Name	City	State
Italy	federico II university, department of nephrology	Naples

Sponsors (1)

Lead Sponsor	Collaborator
Federico II University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in plasma p-cresol concentration	Fasting blood samples were drawn for the p-cresol plasma level	30 days	No
Secondary	composite outcome of gastrointestinal symptoms	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)	30 days	No