Effect of Lactobacillus Rhamnosus on Serum Uremic Toxins in Hemodialysis

Hemodialysis Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03527680
• Other study ID #: IRCT20154182017N21
• Status: Completed
• Phase: N/A
• Start date: September 1, 2016
• Est. completion date: December 30, 2016

Study information

• Verified date: May 2018
• Source: Shahid Beheshti University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: December 30, 2016
• Est. primary completion date: November 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hemodialysis Complication

Intervention

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

Drug:
• Placebo - Cap
daily one capsule of placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
nooshin dalili

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pre- and post-treatment p-cresol levels		4 weeks