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

NCT ID: NCT06421883

Last Updated: 2024-05-20

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-15
• Study Completion Date: 2024-10-15

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 urea,serum 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 CKD's 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 and/or 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

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Experimental probiotic group

Experimental probiotic group patients will receive probiotic 5 billion unit per day with their standard therapy collect blood sample and measure TMAO at baseline and after 3 months

Group Type: EXPERIMENTAL

Lactobacillus containing probiotic

Intervention Type: DIETARY_SUPPLEMENT

Patients will be randomized into two groups each group includes 40 patients:

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.

control group

No Intervention: control group patients will receive their standard therapy only collect blood sample and measure TMAO at baseline and after 3 months

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lactobacillus containing probiotic

Patients will be randomized into two groups each group includes 40 patients:

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

probiotic

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Al-Azhar University

OTHER

Sponsor Role: lead

Responsible Party

Nehal Kamal Bazid

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Al Azhar University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

Interventional clinical trial

Identifier Type: -

Identifier Source: org_study_id