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Study the Effect of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in Hemodialysis Patients - Trial NCT06421883

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.

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NCT06421883
Phase 2/3
Enrolling by invitation
dietary supplement
Trial Details
ClinicalTrials.gov โ€ข NCT06421883
View on ClinicalTrials.gov
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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

Study Focus

End Stage Renal Disease

Lactobacillus containing probiotic

Interventional

dietary supplement

Sponsor & Location

Al-Azhar University

Cairo, Egypt

Timeline & Enrollment

Phase 2/3

Mar 15, 2024

Oct 15, 2024

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 1
Chronic kidney disease, stage 5
Chronic kidney disease, stage 2
Chronic kidney disease, stage 3
Chronic kidney disease, stage 4

Data Source

ClinicalTrials.gov

NCT06421883

Non-Device Trial