NCT05540431

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2022

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 2, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 14, 2022

Completed
11 days until next milestone

Study Start

First participant enrolled

September 25, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 20, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2023

Completed
Last Updated

September 14, 2022

Status Verified

September 1, 2022

Enrollment Period

12 months

First QC Date

September 2, 2022

Last Update Submit

September 13, 2022

Conditions

Uremic Toxin

Keywords

Indoxyl sulfate

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (1)

  • Nutrition status

    Baseline to 6 week

Study Arms (3)

Activated charcoal

OTHER

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

Probiotic

OTHER

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

Control group

OTHER

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

Other: No intervention

Interventions

Activated CharcoalDRUG

RCT

Activated charcoal
ProbioticDIETARY_SUPPLEMENT

RCT

Probiotic
No interventionOTHER

RCT

Control group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with age more than 18 years old;
  • Patients with CKD;
  • Both genders will be included.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Waleed Khaild Rahman Alkabi

Al-diwanyia, Iraq

Location

Related Publications (1)

  • 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.

    PMID: 29477157BACKGROUND

MeSH Terms

Interventions

CharcoalProbiotics

Intervention Hierarchy (Ancestors)

CarbonElementsInorganic ChemicalsDietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Central Study Contacts

Waleed Khaild Rahman, Bachelor of pharmacy

CONTACT

+9647809763160ph.waleedkhaild99@gmail.com

Ihsan Salah Rabea, Assistant Professor

CONTACT

+9647812516401Ihsans.mohammed@uokufa.edu.iq

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Masking Details
None (Open Label)
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Interventional (clinical trial)
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Evaluation of Protective Effect of Activated Charcoal and Probiotic Against Progression of Chronic Kidney Disease

Study Record Dates

First Submitted

September 2, 2022

First Posted

September 14, 2022

Study Start

September 25, 2022

Primary Completion

September 20, 2023

Study Completion

December 20, 2023

Last Updated

September 14, 2022

Record last verified: 2022-09

Locations

IR(1)