- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02311868
Effect of Short-term Synbiotic Treatment on Plasma P-cresol Levels in Hemodialysis Patients
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: eleonora riccio
- Phone Number: 3396770124
- Email: elyriccio@libero.it
Study Locations
-
-
-
Naples, Italy, 80131
- Recruiting
- federico II university, department of nephrology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: SYNBIOTIC
Patients of this group assumed Probinul-Neutro® po 5g three times a day for 30 day
|
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 Names:
|
PLACEBO_COMPARATOR: Placebo
patients of this group received 5g of placebo 3 times a day for 30 days
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in plasma p-cresol concentration
Time Frame: 30 days
|
Fasting blood samples were drawn for the p-cresol plasma level
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
30 days
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- P-cres Probinul
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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