Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins in Hemodialysis

Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins (Phenol and P-Cresol ) in Hemodialysis Patients: A Double Blind Randomized Clinical Trial

Uremic toxins such as p-cresol and phenol are suggested to be associated with higher mortality in hemodialysis patients. The aim of this study was to investigate the effects of probiotics on serum p-cresol level in hemodialysis patients.

Study Overview

• Status: Completed
• Conditions: Hemodialysis Complication
• Intervention / Treatment: Dietary supplement: Lactobacillus rhamnosus; Drug: Placebo - Cap

Detailed Description

Overall, 42 hemodialysis patients (10 women and 32 men) were divided randomly into the Lactobacillus rhamnosus group (21 patients) and the placebo group (21 patients).

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:• Age more than 20 years

• Acceptable performance of alimentary system
• Ability to drink at least 200 ml of water per day
• No history of being allergic to fungi and yeast
• Absence of acute medical illness
• life expectancy more than 3 months
• Accept and sign the consent

Exclusion Criteria:

• Patient's unwillingness to participate in the study
• History of smoking, peritoneal dialysis (PD) or previous kidney transplantation
• Lactation or pregnancy
• Drug history including antibiotics, prebiotics, probiotics, herbal drugs, psychedelic drugs, flavors.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Lactobacillus rhamnosus; received daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus	Dietary supplement: Lactobacillus rhamnosus; daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus prepared by Tabriz Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris, after meal for 28 days
PLACEBO_COMPARATOR: Placebo; received one placebo capsule per day Infant formula after meal for 28 days	Drug: Placebo - Cap; daily one capsule of placebo; Other Names: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
pre- and post-treatment p-cresol levels	4 weeks

Collaborators and Investigators

• Sponsor: nooshin dalili

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2016
• Primary Completion (ACTUAL): November 30, 2016
• Study Completion (ACTUAL): December 30, 2016

Study Registration Dates

• First Submitted: May 21, 2017
• First Submitted That Met QC Criteria: May 16, 2018
• First Posted (ACTUAL): May 17, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 17, 2018
• Last Update Submitted That Met QC Criteria: May 16, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: IRCT20154182017N21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No