Effect of the Synbiotic Probinul-Neutro® on Gastrointestinal Symptoms and Plasma p-Cresol Level in Chronic Renal Failure
Primary Purpose
Chronic Kidney Disease
Status
Completed
Phase
Phase 4
Locations
Italy
Study Type
Interventional
Intervention
SYNBIOTIC
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring chronic kidney disease, p-cresol, synbiotic
Eligibility Criteria
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
Sites / Locations
- Federico II University of Naples
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
SYNBIOTIC
PLACEBO
Arm Description
Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 days
patients of this group received 5g of placebo 3 times a day for 30 days
Outcomes
Primary Outcome Measures
Changes in plasma p-cresol concentration
Fasting blood samples were drawn for the p-cresol plasma level
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT02008331
First Posted
December 2, 2013
Last Updated
December 6, 2013
Sponsor
Federico II University
1. Study Identification
Unique Protocol Identification Number
NCT02008331
Brief Title
Effect of the Synbiotic Probinul-Neutro® on Gastrointestinal Symptoms and Plasma p-Cresol Level in Chronic Renal Failure
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federico II University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
chronic kidney disease, p-cresol, synbiotic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SYNBIOTIC
Arm Type
Experimental
Arm Description
Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 days
Arm Title
PLACEBO
Arm Type
Placebo Comparator
Arm Description
patients of this group received 5g of placebo 3 times a day for 30 days
Intervention Type
Dietary Supplement
Intervention Name(s)
SYNBIOTIC
Other Intervention Name(s)
Probinul-Neutro® or PLACEBO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in plasma p-cresol concentration
Description
Fasting blood samples were drawn for the p-cresol plasma level
Time Frame
30 days
Secondary Outcome Measure Information:
Title
composite outcome of gastrointestinal symptoms
Description
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)
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruna Guida, MD
Organizational Affiliation
Federico II University of Naples, ITALY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federico II University of Naples
City
Naples
ZIP/Postal Code
80129
Country
Italy
12. IPD Sharing Statement
Citations:
PubMed Identifier
24929795
Citation
Guida B, Germano 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.
Results Reference
derived
Learn more about this trial
Effect of the Synbiotic Probinul-Neutro® on Gastrointestinal Symptoms and Plasma p-Cresol Level in Chronic Renal Failure
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