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

NCT ID: NCT02311868

Last Updated: 2014-12-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2015-02-28

Brief 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.

Detailed 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.

Conditions

Hemodialysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SYNBIOTIC

Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 day

Group Type: EXPERIMENTAL

SYNBIOTIC (Probinul neutro®)

Intervention Type: DIETARY_SUPPLEMENT

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

patients of this group received 5g of placebo 3 times a day for 30 days

Group Type: PLACEBO_COMPARATOR

PLACEBO

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

PROBINUL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Federico II University

OTHER

Sponsor Role: lead

Responsible Party

Eleonora Riccio

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

federico II university, department of nephrology

Naples, Italy, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

eleonora riccio

Role: CONTACT

Phone: 3396770124

Email: elyriccio@libero.it

Facility Contacts

eleonora riccio, md

Role: primary

Other Identifiers

P-cres Probinul

Identifier Type: -

Identifier Source: org_study_id