Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease

Study Overview
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Brief Summary
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Investigate the nephroprotective effect of Activated Charcoal and Probiotic in limiting the progression of renal impairment in patients with chronic kidney disease and improving of renal function test and phosphate level. Condition or disease: chronic kidney disease

Detailed Description
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Chronic kidney disease (CKD) is characterized by a gradual decrease in the glomerular filtration rate (GFR) and proteinuria. CKD is a global health problem, and its incidence has been increasing. The estimated global prevalence of CKD is 8-14%. When kidney function deteriorates gradually, many metabolites accumulate in the body. These accumulated substances, termed as uremic toxins (UTs), can result in adverse pathophysiological outcomes. UTs can affect multiple organs and cause renal fibrosis, vascular calcification, anemia, peripheral arterial disease, adynamic bone disease, adipocyte dysfunction with insulin resistance, impaired immune system, and uremic pruritus. The pathophysiological mechanisms through which UTs cause multiple organ damage are complex and not completely understood. These mechanisms may include inflammation, reactive oxidative stress, cellular transdifferentiation, impaired mitochondria function, intestinal barrier destruction, and changes in intestinal microbiota.

Official Title
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Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease

Conditions
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Uremic Toxin

Intervention / Treatment
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* Drug: Activated Charcoal
* Dietary Supplement: Probiotic
* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with age more than 18 years old; Patients with CKD; Both genders will be included. Exclusion Criteria: Patient with age less than 18 years old; Inability or rejection to take activated charcoal or probiotic; Clinically unstable; Pregnant; Unlikely to adhere to study procedure (eg. due to cognitive limitations, severe psychiatric disorder or alcoholism).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional (clinical trial)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Activated charcoal<br>1st group Oral activated charcoal 20 to 25 patient with CKD will receive standard care plus Activated charcoal capsule (charconut) three times dialy for six weeks. | Drug: Activated Charcoal<br>* RCT<br>|
| Other: Probiotic<br>2nd group Oral probiotic 20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks. | Dietary Supplement: Probiotic<br>* RCT<br>|
| Other: Control group<br>3rd group Control group 20 to 25 patient with CKD will receive standard care only for six weeks. | Other: No intervention<br>* RCT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improving of blood urea | The concentration of blood urea(mmol/L),dL) ) in all blood samples | Baseline to 6 week | 
| Indoxyl sulfate assay | The concentration of human indoxyl sulfates level by elisa technique in the subjects' blood samples | Baseline to 6 week | 
| Improving of serum creatinine mg/dL | The concentration of serum creatinine(mg/dL) in all blood sample | Baseline to 6 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutrition status | The concentration of albumin(g/dL) in the subjects' blood samples | Baseline to 6 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Indoxyl sulfate