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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Uremic Toxin
• Intervention / Treatment: Drug: Activated Charcoal; Dietary supplement: Probiotic; Other: No intervention

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Waleed Khaild Rahman, Bachelor of pharmacy; Phone Number: +9647809763160; Email: ph.waleedkhaild99@gmail.com
• Study Contact Backup: Name: Ihsan Salah Rabea, Assistant Professor; Phone Number: +9647812516401; Email: Ihsans.mohammed@uokufa.edu.iq

Study Locations

• Iraq
  • Al-diwanyia, Iraq
    • Waleed Khaild Rahman Alkabi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Drug: Activated Charcoal; RCT
Other: Probiotic; 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; RCT
Other: Control group; 3rd group Control group 20 to 25 patient with CKD will receive standard care only for six weeks.	Other: No intervention; RCT

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Waleed Khaild Rahman Kareem Al-kabi

Publications and helpful links

General Publications

• Saran R, Robinson B, Abbott KC, Agodoa LYC, Bhave N, Bragg-Gresham J, Balkrishnan R, Dietrich X, Eckard A, Eggers PW, Gaipov A, Gillen D, Gipson D, Hailpern SM, Hall YN, Han Y, He K, Herman W, Heung M, Hirth RA, Hutton D, Jacobsen SJ, Jin Y, Kalantar-Zadeh K, Kapke A, Kovesdy CP, Lavallee D, Leslie J, McCullough K, Modi Z, Molnar MZ, Montez-Rath M, Moradi H, Morgenstern H, Mukhopadhyay P, Nallamothu B, Nguyen DV, Norris KC, O'Hare AM, Obi Y, Park C, Pearson J, Pisoni R, Potukuchi PK, Rao P, Repeck K, Rhee CM, Schrager J, Schaubel DE, Selewski DT, Shaw SF, Shi JM, Shieu M, Sim JJ, Soohoo M, Steffick D, Streja E, Sumida K, Tamura MK, Tilea A, Tong L, Wang D, Wang M, Woodside KJ, Xin X, Yin M, You AS, Zhou H, Shahinian V. US Renal Data System 2017 Annual Data Report: Epidemiology of Kidney Disease in the United States. Am J Kidney Dis. 2018 Mar;71(3 Suppl 1):A7. doi: 10.1053/j.ajkd.2018.01.002. No abstract available. Erratum In: Am J Kidney Dis. 2018 Apr;71(4):501.

Study record dates

Study Major Dates

• Study Start (Anticipated): September 25, 2022
• Primary Completion (Anticipated): September 20, 2023
• Study Completion (Anticipated): December 20, 2023

Study Registration Dates

• First Submitted: September 2, 2022
• First Submitted That Met QC Criteria: September 13, 2022
• First Posted (Actual): September 14, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2022
• Last Update Submitted That Met QC Criteria: September 13, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Indoxyl sulfate
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Physiological Effects of Drugs; Protective Agents; Antidotes; Charcoal
• Other Study ID Numbers: Uremic toxin in CKD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No