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

Waleed Khaild Rahman Kareem Al-kabi

Status and phase: Not yet enrolling; Phase 3; Phase 2

Conditions: Uremic Toxin

Treatments: Drug: Activated Charcoal; Dietary Supplement: Probiotic; Other: No intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT05540431

Uremic toxin in CKD

Details and patient eligibility

About

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

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Activated charcoal

Other group

Description:

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.

Treatment:

Drug: Activated Charcoal

Probiotic

Other group

Description:

2nd group Oral probiotic 20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks.

Treatment:

Dietary Supplement: Probiotic

Control group

Other group

Description:

3rd group Control group 20 to 25 patient with CKD will receive standard care only for six weeks.

Treatment:

Other: No intervention