Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421883
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-20
First Post:
2024-05-15
Brief Title:
Study the Effect of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in Hemodialysis Patients
Sponsor:
Al-Azhar University
Organization:
Al-Azhar University
Study Overview
Official Title:
The Potential Impact of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in End Stage Renal Disease Patients Undergoing Hemodialysis
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
probiotic
Brief 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 ureaserum creatinine albumin uric acid Complete blood count CBC
C-reactive protein CRP
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 ureaserum creatinine albumin uric acid Complete blood count CBC
C-reactive protein CRP
Detailed Description:
Chronic Kidney Disease CKD is considered as a major public health problem as it can lead to end-stage kidney failure which requires replacement therapy A prompt and accurate diagnosis along with the appropriate treatment can delay CKDs progression End-stage renal disease ESRD is associated with significant alterations in cardiovascular function homeostasis of body fluid electrolytes and acid-base equilibrium bone metabolism erythropoiesis and blood coagulation The prevalence of ESRD is increasing rapidly worldwide as is the number of patients requiring surgery under general anesthesia Patients with ESRD have significantly higher risks of perioperative morbidity and mortality due to multiple comorbidities Trimethylamine N-oxide TMAO is a gut microbiota metabolite derived from trimethylamine containing nutrient precursors such as choline L-carnitine and betaine An increasing number of clinical studies have demonstrated a strong relationship between elevated plasma TMAO levels and adverse cardiovascular events It is commonly agreed that TMAO acts as both an independent risk factor and a prognostic index for patients with cardiovascular disease TMAO is considered as a potential biomarker andor therapeutic target for diagnosis and treatment of patients with cardiovascular disease Probiotic work as antagonist for those strains which are responsible for the synthesis of TMAO precursor molecules in the gut and modulate miRNAs associated with the genes which are responsible for TMA lyases and ultimately play a role in conversion of diet precursor into TMA Control group 40 patients will receive their standard therapy only Intervention group probiotic group 40 patients will receive probiotic 5 billion unit per day with their standard therapy for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None