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

NCT02311868 | Unknown Phase 4

• 1 other identifier: P-cres Probinul
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Changes in plasma p-cresol concentration

  Fasting blood samples were drawn for the p-cresol plasma level

  30 days

Secondary Outcomes (1)

• composite outcome of gastrointestinal symptoms

  30 days

Study Arms (2)

SYNBIOTIC

EXPERIMENTAL

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

Dietary Supplement: SYNBIOTIC (Probinul neutro®)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: PLACEBO

Interventions

SYNBIOTIC (Probinul neutro®) 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.

Also known as: PROBINUL

SYNBIOTIC

PLACEBO 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• hemodialysis
• age \>18 years

You may not qualify if:

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

Sponsors & Collaborators

• Federico II University: lead

Study Sites (1)

federico II university, department of nephrology

Naples, Italy, 80131, Italy

RECRUITING

MeSH Terms

Interventions

Synbiotics

Intervention Hierarchy (Ancestors)

Prebiotics; Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Probiotics; Food and Beverages

Central Study Contacts

eleonora riccio

CONTACT

3396770124; elyriccio@libero.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 4, 2014
• First Posted: December 9, 2014
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

IT (1)