Effect of Short-term Synbiotic Treatment on Plasma P-cresol Levels in Hemodialysis Patients
|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
|Condition or disease||Intervention/treatment||Phase|
|Hemodialysis||Dietary Supplement: SYNBIOTIC (Probinul neutro®) Dietary Supplement: PLACEBO||Phase 4|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||February 2015|
|Estimated Study Completion Date :||February 2015|
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.
- Changes in plasma p-cresol concentration [ Time Frame: 30 days ]Fasting blood samples were drawn for the p-cresol plasma level
- 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)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02311868
|Contact: eleonora email@example.com|
|federico II university, department of nephrology||Recruiting|
|Naples, Italy, 80131|
|Contact: eleonora riccio, md 3396770124 firstname.lastname@example.org|