The Effect of Probiotics vs Activated Charcoal in the Management of CKD Patients Suffering From Uremic Pruritus.

NCT06579066 | Not Yet Recruiting Phase 2

• 1 other identifier: Uremic Pruitus
• Study Type: interventional
• Target: 123
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate the efficacy and safety of probiotics versus activated charcoal in management of chronic kidney disease patients suffering from uremic pruritus. Patient data collection Demographic data:The following data will be collected from the patient records; including age, sex, weight, height. History Taking :Including patient's medical history, past surgical history, family medical history, and medications the patient is taking or may have recently stopped taking. A patient's medical history may also include information about allergies, etiology of uremic pruritus. Laboratory examinations:The following laboratory data to be measured at baseline and after the duration of treatment (4 weeks)

1. 1.Serum levels of indoxyl sulfate (IS)
2. 2.Kidney Function tests: BUN, Creatinine
3. 3.Electrolytes test: sodium, potassium, chloride ,ionized calcium, phosphorus
4. 4.measure Visual Analoge Scale Score(VAS).
5. 5.measure Dermatology life quality index (DLQI).

Conditions

Chronic Kidney Disease; Uremic Pruritus

Keywords

Probiotics; Activated Charcoal; uremic pruritus

Outcome Measures

Primary Outcomes (3)

• Change in serum Indoxyl sulfate (IS) level

  IS is one of the most potent protein bound uremic toxins . mesasuring serum indoxyl sulfate level at baseline and after a 4 weeks trial period by using ELISA kits.

  Four weeks

• Change in visual Analog scale (VAS) score.

  A 10 cm horizontal line marked from zero (no pruritus) to 10 (worst possible pruritus). The pruritus will be assessed subjectively and scored at baseline and after a 4 weeks trial period .

  Four weeks

• Change in Dermatology life quality index (DLQI)

  10-Item questionnaire aiming to measure how much skin problem has affected on QOL . mesasuring DLQI at baseline and after a 4 weeks trial period .

  Four weeks

Secondary Outcomes (1)

• Evaluation of the safety of probiotics supplementation and activated charcoal in patients with uremic pruritus.

  Four weeks

Study Arms (3)

probiotics

EXPERIMENTAL

Patients will administer Linex ® capsule orally along with the standard care of therapy for duration of 4 weeks. Dose: Capsule once daily

Drug: Probiotic Blend Capsule

activated charcoal

EXPERIMENTAL

Patients will administer Charclone® 1000mg tab orally along with the standard care of therapy for duration of 4 weeks. Dose: Tablet three times daily.

Drug: Activated Charcoal

Control

NO INTERVENTION

Patients will administer standard care of therapy alone Telfast®120mg tablet for duration of 4 weeks.. Dose: Tablet once daily

Interventions

Probiotic Blend Capsule DRUG

Patients will administer (probiotics) Linex® one capsule daily orally along with the standard care of therapy for duration of 4 weeks.

Also known as: linex®

probiotics

Activated Charcoal DRUG

Patients will administer (activated charcoal) Charclone® 1000MG Tablet three times daily orally along with the standard care of therapy for duration of 4 weeks.

Also known as: Charclone®

activated charcoal

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult Patients with uremic pruritus aged from 18 years and older will be enrolled in the study.

You may not qualify if:

• Patients with psoriasis, atopic dermatitis or any other condition that can justify pruritus.
• Patient undergoing dialysis.
• Patients with known allergy to Activated charcoal or probiotics supplements.
• Patients who are non-compliant.

Sponsors & Collaborators

• Ain Shams University: lead

Related Publications (3)

• Akl EM, El-Eraki JM, Elfallah AA, Mohamed NH, Maher AM, Mansour AE, Abdelsalam OH. Does Indoxyl Sulfate Have a Role in Uremic Pruritus? A Laboratory and Interventional Study. J Cutan Med Surg. 2024 Jan-Feb;28(1):44-50. doi: 10.1177/12034754231220935. Epub 2023 Dec 29.

  PMID: 38156627 BACKGROUND

• Kim SH, Jhee JH, Choi HY, Lee SH, Shin SK, Lee SY, Yang DH, Yi JH, Han SW, Jo YI, Park HC. New oral spherical carbon adsorbent effectively reduces serum indoxyl sulfate levels in moderate to advanced chronic kidney disease patients: a multicenter, prospective, open-label study. BMC Nephrol. 2020 Jul 31;21(1):317. doi: 10.1186/s12882-020-01971-x.

  PMID: 32736531 BACKGROUND

• Szanto M, Dozsa A, Antal D, Szabo K, Kemeny L, Bai P. Targeting the gut-skin axis-Probiotics as new tools for skin disorder management? Exp Dermatol. 2019 Nov;28(11):1210-1218. doi: 10.1111/exd.14016. Epub 2019 Aug 28.

  PMID: 31386766 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Anthrax

Interventions

Charcoal

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bacillaceae Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Carbon; Elements; Inorganic Chemicals

Study Officials

• Aliaa Mohamed

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aliaa Mohamed Ashraf

CONTACT

01064831049; aliaa.mohamed22@pharma.asu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Aliaa Mohamed

Model Details: One hundred twenty three patients who will fit the inclusion criteria will be randomly divided into 3 groups: Group 1 (Probiotics group): 41 Patients will administer Linex®(one capsule daily) orally along with the standard care of therapy for duration of 4 weeks. Group 2 (activated charcoal): 41 Patients will administer Charclone® 1000MG Tab (Tablet three times daily) orally along with the standard care of therapy for duration of 4 weeks. Patients will take activated charcoal dose at least 2 hours before taking other drugs. Group 3 (Control group) : 41 Patients will administer standard care of therapy alone (fexofenadine) TELFAST®120mg tablet once daily

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: August 30, 2024
• Study Start: September 1, 2024
• Primary Completion: February 1, 2025
• Study Completion: March 1, 2025
• Last Updated: August 30, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share