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

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

Status
UNKNOWN
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05540431
Enrollment
60
Registered
2022-09-14
Start date
2022-09-25
Completion date
2023-12-20
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uremic Toxin

Keywords

Indoxyl sulfate

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.

Interventions

OTHERNo intervention

RCT

DIETARY_SUPPLEMENTProbiotic

RCT

Sponsors

Waleed Khaild Rahman Kareem Al-kabi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Masking description

None (Open Label)

Intervention model description

Interventional (clinical trial)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
Yes

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).

Design outcomes

Primary

MeasureTime frameDescription
Improving of blood ureaBaseline to 6 weekThe concentration of blood urea(mmol/L),dL) ) in all blood samples
Indoxyl sulfate assayBaseline to 6 weekThe concentration of human indoxyl sulfates level by elisa technique in the subjects' blood samples
Improving of serum creatinine mg/dLBaseline to 6 weekThe concentration of serum creatinine(mg/dL) in all blood sample

Secondary

MeasureTime frameDescription
Nutrition statusBaseline to 6 weekThe concentration of albumin(g/dL) in the subjects' blood samples

Countries

Iraq

Contacts

Primary ContactWaleed Khaild Rahman, Bachelor of pharmacy
ph.waleedkhaild99@gmail.com+9647809763160
Backup ContactIhsan Salah Rabea, Assistant Professor
Ihsans.mohammed@uokufa.edu.iq+9647812516401

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026