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

Primary Purpose

Uremic Toxin

Status
Not yet recruiting
Phase
Phase 2
Locations
Iraq
Study Type
Interventional
Intervention
Activated Charcoal
Probiotic
No intervention
Sponsored by
Waleed Khaild Rahman Kareem Al-kabi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Uremic Toxin focused on measuring Indoxyl sulfate

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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).

Sites / Locations

  • Waleed Khaild Rahman Alkabi

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Other

Other

Arm Label

Activated charcoal

Probiotic

Control group

Arm 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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Nutrition status
The concentration of albumin(g/dL) in the subjects' blood samples

Full Information

First Posted
September 2, 2022
Last Updated
September 13, 2022
Sponsor
Waleed Khaild Rahman Kareem Al-kabi
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1. Study Identification

Unique Protocol Identification Number
NCT05540431
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 25, 2022 (Anticipated)
Primary Completion Date
September 20, 2023 (Anticipated)
Study Completion Date
December 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Waleed Khaild Rahman Kareem Al-kabi

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uremic Toxin
Keywords
Indoxyl sulfate

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Interventional (clinical trial)
Masking
None (Open Label)
Masking Description
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Activated charcoal
Arm Type
Other
Arm 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.
Arm Title
Probiotic
Arm Type
Other
Arm Description
2nd group Oral probiotic 20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks.
Arm Title
Control group
Arm Type
Other
Arm Description
3rd group Control group 20 to 25 patient with CKD will receive standard care only for six weeks.
Intervention Type
Drug
Intervention Name(s)
Activated Charcoal
Intervention Description
RCT
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
RCT
Intervention Type
Other
Intervention Name(s)
No intervention
Intervention Description
RCT
Primary Outcome Measure Information:
Title
Improving of blood urea
Description
The concentration of blood urea(mmol/L),dL) ) in all blood samples
Time Frame
Baseline to 6 week
Title
Indoxyl sulfate assay
Description
The concentration of human indoxyl sulfates level by elisa technique in the subjects' blood samples
Time Frame
Baseline to 6 week
Title
Improving of serum creatinine mg/dL
Description
The concentration of serum creatinine(mg/dL) in all blood sample
Time Frame
Baseline to 6 week
Secondary Outcome Measure Information:
Title
Nutrition status
Description
The concentration of albumin(g/dL) in the subjects' blood samples
Time Frame
Baseline to 6 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Waleed Khaild Rahman, Bachelor of pharmacy
Phone
+9647809763160
Email
ph.waleedkhaild99@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ihsan Salah Rabea, Assistant Professor
Phone
+9647812516401
Email
Ihsans.mohammed@uokufa.edu.iq
Facility Information:
Facility Name
Waleed Khaild Rahman Alkabi
City
Al-diwanyia
Country
Iraq

12. IPD Sharing Statement

Citations:
PubMed Identifier
29477157
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. Erratum In: Am J Kidney Dis. 2018 Apr;71(4):501.
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Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease

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