## Protocol Section
### Identification Module
**NCT ID:** NCT06421883

**Acronym:** probiotic

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

**Official Title:** The Potential Impact of Probiotic Supplementation on Trimethylamine-N-Oxide Plasma Level in End Stage Renal Disease Patients Undergoing Hemodialysis

#### Organization Study ID Info
**ID:** Interventional clinical trial
#### Organization
**Class:** OTHER
**Full Name:** Al-Azhar University
### Status Module
#### Completion Date
**Date:** 2024-10-15

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-20

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** ENROLLING_BY_INVITATION

#### Primary Completion Date
**Date:** 2024-06-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-03-15

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-20
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-15
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Al-Azhar University

#### Responsible Party

**Investigator Affiliation:** Al-Azhar University

**Investigator Full Name:** Nehal Kamal Bazid

**Investigator Title:** Principal investigator

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- End Stage Renal Disease

**Keywords:**

- hemodialysis

- probiotic

- Trimethylamine-N-Oxide

- TMAO

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** 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.

##### Masking Info

**Masking:** NONE

**Masking Description:** (Open Label)

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 80

**Type:** ESTIMATED

**Phases:**

- PHASE2

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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

**Intervention Names:**

- Dietary Supplement: Lactobacillus containing probiotic

**Label:** Experimental probiotic group

**Type:** EXPERIMENTAL

#### Arm Group 2

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

**Label:** control group

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Experimental probiotic group

**Description:** 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.

**Name:** Lactobacillus containing probiotic

**Other Names:**

- probiotic

**Type:** DIETARY_SUPPLEMENT

### Outcomes Module

#### Primary Outcomes

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

**Measure:** change in Trimethylamine-N-Oxide Plasma Level

**Time Frame:** 3 months

### Eligibility Module

**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.

**Maximum Age:** 60 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Cairo

**Country:** Egypt

**Facility:** Al Azhar University

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000014570

- Term: Urologic Diseases

- ID: D000052776

- Term: Female Urogenital Diseases

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000052801

- Term: Male Urogenital Diseases

- ID: D000051436

- Term: Renal Insufficiency, Chronic

- ID: D000051437

- Term: Renal Insufficiency

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M10698

- Name: Kidney Diseases

- Relevance: HIGH

- As Found: Renal Disease

- ID: M10699

- Name: Kidney Failure, Chronic

- Relevance: HIGH

- As Found: End Stage Renal Disease

- ID: M26718

- Name: Renal Insufficiency

- Relevance: LOW

- As Found: Unknown

- ID: M17319

- Name: Urologic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M27095

- Name: Male Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M26717

- Name: Renal Insufficiency, Chronic

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000007674

- Term: Kidney Diseases

- ID: D000007676

- Term: Kidney Failure, Chronic

### Intervention Browse Module - Browse Branches

- Abbrev: Ot

- Name: Other Dietary Supplements

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T355

- Name: Acidophilus

- Relevance: HIGH

- As Found: Students

### Misc Info Module

- Version Holder: 2024-05-31
