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

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ClinicalTrials.gov Identifier: NCT02008331
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : December 11, 2013
Sponsor:
Information provided by (Responsible Party):
Bruna Guida, Federico II University

Tracking Information
First Submitted Date  ICMJE December 2, 2013
First Posted Date  ICMJE December 11, 2013
Last Update Posted Date December 11, 2013
Study Start Date  ICMJE April 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
Changes in plasma p-cresol concentration [ Time Frame: 30 days ]
Fasting blood samples were drawn for the p-cresol plasma level
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: December 6, 2013)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of the Synbiotic Probinul-Neutro® on Gastrointestinal Symptoms and Plasma p-Cresol Level in Chronic Renal Failure
Official Title  ICMJE EFFECT OF SHORT-TERM TREATMENT WITH THE SYNBIOTIC PROBINUL-NEUTRO® ON GASTROINTESTINAL SYMPTOMS AND CIRCULATING PLASMA p-CRESOL LEVEL IN PATIENTS WITH CHRONIC RENAL FAILURE: A RANDOMIZED DOUBLE BLIND PILOT STUDY.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Kidney Disease
Intervention  ICMJE Dietary Supplement: SYNBIOTIC

INTERVENTION: 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.

Other Name: Probinul-Neutro® or PLACEBO
Study Arms  ICMJE
  • Experimental: SYNBIOTIC
    Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 days
    Intervention: Dietary Supplement: SYNBIOTIC
  • Placebo Comparator: PLACEBO
    patients of this group received 5g of placebo 3 times a day for 30 days
Publications * Guida B, Germanò R, Trio R, Russo D, Memoli B, Grumetto L, Barbato F, Cataldi M. Effect of short-term synbiotic treatment on plasma p-cresol levels in patients with chronic renal failure: a randomized clinical trial. Nutr Metab Cardiovasc Dis. 2014 Sep;24(9):1043-9. doi: 10.1016/j.numecd.2014.04.007. Epub 2014 May 2.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 6, 2013)
30
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2013
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02008331
Other Study ID Numbers  ICMJE Guida56
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Bruna Guida, Federico II University
Study Sponsor  ICMJE Federico II University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Bruna Guida, MD Federico II University of Naples, ITALY
PRS Account Federico II University
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP