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

Phase 2

Not yet recruiting

• Conditions: Uremic Toxin
• Interventions: Drug: Activated Charcoal; Dietary Supplement: Probiotic; Other: No intervention

• Registration Number: NCT05540431
• Lead Sponsor: Waleed Khaild Rahman Kareem Al-kabi

Brief Summary

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

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.

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-02
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14
• Study Start: 2022-09-25
• Primary Completion: 2023-09-20
• Study Completion: 2023-12-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Activated charcoal	Activated Charcoal	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.
Probiotic	Probiotic	2nd group Oral probiotic 20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks.
Control group	No intervention	3rd group Control group 20 to 25 patient with CKD will receive standard care only for six weeks.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Nutrition status	Baseline to 6 week	The concentration of albumin(g/dL) in the subjects' blood samples

Trial Locations

Locations (1)

Waleed Khaild Rahman Alkabi; 🇮🇶 Al-diwanyia, Iraq