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NCT06421883Enrolling by invitation

Study the Effect of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in Hemodialysis Patients

The Potential Impact of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in End Stage Renal Disease Patients Undergoing Hemodialysis
Al-Azhar UniversityPhase 2/3ClinicalTrials.govdietary supplement
Verified
Study focus
Disease/Condition
End Stage Renal Disease
Drug/Device/Intervention
Lactobacillus containing probiotic
Study type
Interventional
Intervention type
dietary supplement
Sponsor & location
Primary sponsor
Al-Azhar University
Location
Cairo, Egypt
Timeline & enrollment
Phase
Phase 2/3
Start date
Mar 15, 2024
End date
Oct 15, 2024
Enrollment
80 participants
Primary outcome

change in Trimethylamine-N-Oxide Plasma Level

Summary

The goal of this clinical trial is to learn if probiotic has an effect on
 Trimethylamine-N-Oxide Plasma Level in plasma, which represent strong risk factor for
 Atherosclerosis in end stage renal disease patients who undergoing hemodialysis the main
 questions to answer are : Does probiotic lower Trimethylamine-N-Oxide concentration? does
 probiotic participating in decreasing risk of atherosclerosis in end stage renal disease
 patients undergoing hemodialysis ? research will compare between patients who are taking
 probiotic and control group (taking no drug) participants will take probiotic for 3 months
 visit the clinic once every 2 weeks for checkups and tests
 
 All Patients will be subjected to the following:
 
 1. Informed consent.
 
 2. Demographics and history taking: Using Patient Data sheet.
 
 3. Laboratory evaluation including:
 
 Kidney function tests: blood urea,serum creatinine, albumin ,uric acid. Complete blood count
 (CBC).
 
 C-reactive protein (CRP).

ICD-10 classifications
Chronic kidney disease, stage 1Chronic kidney disease, stage 5Chronic kidney disease, stage 2Chronic kidney disease, stage 3Chronic kidney disease, stage 4
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06421883
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06421883 through Pure Global AI's free database. This Phase 2/3 trial is sponsored by Al-Azhar University and is currently Enrolling by invitation. The study focuses on End Stage Renal Disease. Target enrollment is 80 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.