Clinical trial NCT05540431: Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease
Official title: Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Uremic Toxin
Keywords: Indoxyl sulfate
Lead sponsor: Kufa University
Sponsor class: OTHER
First posted: 2022-09-14
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional (clinical trial)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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).

Primary outcomes:
measure: Improving of blood urea
timeFrame: Baseline to 6 week
measure: Indoxyl sulfate assay
timeFrame: Baseline to 6 week
measure: Improving of serum creatinine mg/dL
timeFrame: Baseline to 6 week
Secondary outcomes:
measure: Nutrition status
timeFrame: Baseline to 6 week
Other outcomes:
Locations:
city: Al-diwanyia
country: Iraq
facility: Waleed Khaild Rahman Alkabi
Study officials:
References:
citation: 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.