End Stage Renal Disease Clinical Trial
— probioticOfficial title:
The Potential Impact of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in End Stage Renal Disease Patients Undergoing Hemodialysis
Verified date | May 2024 |
Source | Al-Azhar University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Enrolling by invitation |
Enrollment | 80 |
Est. completion date | October 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients who diagnosed as End Stage Renal Disease with hemodialysis - Aged 18 years or older. - Both sexes. - No known contraindications to therapy with probiotic - Patients who accept to participate in the study. Exclusion Criteria: - Pregnant and breast-feeding women - History of severe allergic reactions to the study medication. - Current medication regimen including probiotic - chronic liver disease - Patients receiving chronic anti-inflammatory therapy - Non-compliant patients: those who did not adhere to the medications during the study. |
Country | Name | City | State |
---|---|---|---|
Egypt | Al Azhar University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Al-Azhar University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | change in Trimethylamine-N-Oxide Plasma Level | probiotic is expected to lower Trimethylamine-N-Oxide Plasma Level in dialysis patients | 3 months |
Status | Clinical Trial | Phase | |
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