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

NCT06421883 | Enrolling By Invitation Phase 2

• 1 other identifier: Interventional clinical trial
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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. 1.Informed consent.
2. 2.Demographics and history taking: Using Patient Data sheet.
3. 3.Laboratory evaluation including:

Conditions

End Stage Renal Disease

Keywords

hemodialysis; probiotic; Trimethylamine-N-Oxide; TMAO

Outcome Measures

Primary Outcomes (1)

• change in Trimethylamine-N-Oxide Plasma Level

  probiotic is expected to lower Trimethylamine-N-Oxide Plasma Level in dialysis patients

  3 months

Study Arms (2)

Experimental probiotic group

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus containing probiotic

control group

NO INTERVENTION

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

Interventions

Lactobacillus containing probiotic 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.

Also known as: probiotic

Experimental probiotic group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al Azhar University

Cairo, Egypt

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: (Open Label)
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 15, 2024
• First Posted: May 20, 2024
• Study Start: March 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: October 15, 2024
• Last Updated: May 20, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)