Effect of Pre- and Probiotics on P-cresol Plasma Levels in Patients Bearing a Kidney Allograft
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|ClinicalTrials.gov Identifier: NCT02179229|
Recruitment Status : Unknown
Verified June 2014 by Bruna Guida, Federico II University.
Recruitment status was: Recruiting
First Posted : July 1, 2014
Last Update Posted : July 2, 2014
|Condition or disease||Intervention/treatment||Phase|
|Renal Insufficiency, Chronic||Dietary Supplement: CONTROL Dietary Supplement: SYNBIOTIC||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Effect of Pre- and Probiotics on P-cresol Plasma Levels in Patients Bearing a Kidney Allograft|
|Study Start Date :||June 2014|
|Estimated Primary Completion Date :||June 2015|
|Estimated Study Completion Date :||August 2015|
Placebo Comparator: CONTROL
Patient in the CONTROL arm will receive a powder containing only tapioca-resistant starch comparable in colour, texture and taste to the synbiotic.
Dietary Supplement: CONTROL
Placebo will be taken at home for four weeks as 5 g powder packets to be dissolved in water three times a day far from meals.
Other Name: PLACEBO
Patients in this group will receive Probinul neutro® a synbiotic preparation containing (perpacket): lyophilised bacteria (5×109 Lactobacillus plantarum, 2×109 Lactobacillus casei subsp. rhamnosus and 2×109 Lactobacillus gasseri, 1×109 Bifidobacterium infantis and 1×109 Bifidobacterium longum, 1×109 Lactobacillus acidophilus, 1×109 Lactobacillus salivarius and 1×109 Lactobacillus sporogenes and 5×109 Streptococcus thermophilus), prebiotic inulin (2.2 g; VB Beneo Synergy 1) and 1.3 g of tapioca-resistant starch.
Dietary Supplement: SYNBIOTIC
Probinul Neutro® will be taken at home for four weeks as 5 g powder packets to be dissolved in water three times a day far from meals.
Other Name: Probinul Neutro®
- Change in p-cresol plasma concentration [ Time Frame: one month ]Total p-cresol (free and glucurono- or sulpho-conjugates) plasma concentration will be assessed by reverse phase HPLC at baseline, 15 and 30 days after starting synbiotic treatment.
- Change in bowel habits [ Time Frame: one month ]Defecation frequency or ease, stool shape, upper or lower abdominal pain, frequency of borborygms or flatus will be assessed by asking the patients to fill a a form for the scored evaluation of GI symptoms and stool characteristics
- Change in plasma immunosuppressant drug concentration [ Time Frame: one month ]Plasma concentration of the different immunosuppressant assumed by the patient (mycophenolate mofetil, cyclosporin, tacrolimus, everolimus or sirolimus) will be assessed at baseline, 15 and 30 days after the beginning of the study.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02179229
|Nutrition Unit of the Federico II University of Naples||Recruiting|
|Naples, Italy, 80131|
|Contact: Bruna Guida, MD 0039-081-7462102 email@example.com|
|Contact: Rossella Trio, BSci firstname.lastname@example.org|
|Principal Investigator: Bruna Guida, MD|
|Principal Investigator:||Bruna Guida, MD||Federico II University of Naples|