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

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ClinicalTrials.gov Identifier: NCT02311868
Recruitment Status : Unknown
Verified December 2014 by Eleonora Riccio, Federico II University.
Recruitment status was:  Recruiting
First Posted : December 9, 2014
Last Update Posted : December 9, 2014
Sponsor:
Information provided by (Responsible Party):
Eleonora Riccio, Federico II University

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.

Condition or disease Intervention/treatment Phase
Hemodialysis Dietary Supplement: SYNBIOTIC (Probinul neutro®) Dietary Supplement: PLACEBO Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : December 2014
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: SYNBIOTIC
Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 day
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.
Other Name: PROBINUL

Placebo Comparator: Placebo
patients of this group received 5g of placebo 3 times a day for 30 days
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.




Primary Outcome Measures :
  1. Changes in plasma p-cresol concentration [ Time Frame: 30 days ]
    Fasting blood samples were drawn for the p-cresol plasma level


Secondary Outcome Measures :
  1. composite outcome of gastrointestinal symptoms [ Time Frame: 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)



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311868


Contacts
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Contact: eleonora riccio 3396770124 elyriccio@libero.it

Locations
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Italy
federico II university, department of nephrology Recruiting
Naples, Italy, 80131
Contact: eleonora riccio, md    3396770124    elyriccio@libero.it   
Sponsors and Collaborators
Federico II University
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Responsible Party: Eleonora Riccio, MD, Federico II University
ClinicalTrials.gov Identifier: NCT02311868    
Other Study ID Numbers: P-cres Probinul
First Posted: December 9, 2014    Key Record Dates
Last Update Posted: December 9, 2014
Last Verified: December 2014