NCT03527680

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2017

Completed
12 months until next milestone

First Posted

Study publicly available on registry

May 17, 2018

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

3 months

First QC Date

May 21, 2017

Last Update Submit

May 16, 2018

Conditions

Hemodialysis Complication

Outcome Measures

Primary Outcomes (1)

  • pre- and post-treatment p-cresol levels

    4 weeks

Study Arms (2)

Lactobacillus rhamnosus

EXPERIMENTAL

received daily one capsule containing 1.6\*107 CFU of Lactobacillus Rhamnosus

Dietary Supplement: Lactobacillus rhamnosus

Placebo

PLACEBO COMPARATOR

received one placebo capsule per day Infant formula after meal for 28 days

Drug: Placebo - Cap

Interventions

Lactobacillus rhamnosusDIETARY_SUPPLEMENT

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

Lactobacillus rhamnosus
Placebo - CapDRUG

daily one capsule of placebo

Also known as: placebo
Placebo

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant Professor of SBMU

Study Record Dates

First Submitted

May 21, 2017

First Posted

May 17, 2018

Study Start

September 1, 2016

Primary Completion

November 30, 2016

Study Completion

December 30, 2016

Last Updated

May 17, 2018

Record last verified: 2018-05