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

NCT ID: NCT05540431

Last Updated: 2022-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-25

Study Completion Date

2023-12-20

Brief Summary

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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

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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.

Conditions

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Uremic Toxin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional (clinical trial)
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

None (Open Label)

Study Groups

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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.

Group Type OTHER

Activated Charcoal

Intervention Type DRUG

RCT

Probiotic

2nd group

Oral probiotic

20 to 25 patient with CKD will receive standard care plus Probiotic tablet twice dialy for six weeks.

Group Type OTHER

Probiotic

Intervention Type DIETARY_SUPPLEMENT

RCT

Control group

3rd group

Control group

20 to 25 patient with CKD will receive standard care only for six weeks.

Group Type OTHER

No intervention

Intervention Type OTHER

RCT

Interventions

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Activated Charcoal

RCT

Intervention Type DRUG

Probiotic

RCT

Intervention Type DIETARY_SUPPLEMENT

No intervention

RCT

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Waleed Khaild Rahman Kareem Al-kabi

OTHER

Sponsor Role lead

Responsible Party

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Waleed Khaild Rahman Kareem Al-kabi

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

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Waleed Khaild Rahman Alkabi

Al-diwanyia, , Iraq

Site Status

Countries

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Iraq

Central Contacts

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Waleed Khaild Rahman, Bachelor of pharmacy

Role: CONTACT

+9647809763160

Ihsan Salah Rabea, Assistant Professor

Role: CONTACT

+9647812516401

References

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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.

Reference Type BACKGROUND
PMID: 29477157 (View on PubMed)

Other Identifiers

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Uremic toxin in CKD

Identifier Type: -

Identifier Source: org_study_id

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