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

The Effect of Probiotics Versus Activated Charcoal in the Management of Chronic Kidney Disease Patients Suffering From Uremic Pruritus.

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06579066
Enrollment
123
Registered
2024-08-30
Start date
2024-09-30
Completion date
2025-03-31
Last updated
2024-08-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Uremic Pruritus

Keywords

Probiotics, Activated Charcoal, uremic pruritus

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

Detailed description

Chronic kidney disease-associated pruritus (CKD-aP) , also called uremic pruritus (UP) is a critical problem defined as un pleasant sensation that desire to itch and scratch experienced by people with chronic kidney disease (CKD) patients . Pruritus is the most common skin symptoms related with uremia and has a major clinical effect being associated strongly with poor quality of life , impaired sleep and increased mortality, so it's important to explore an efficient treatment option for it. Although the pathogenesis of pruritus remains largely unclear, it is demonstrated that pruritus is mainly ascribed to the retention of uremic solutes. Gut microbiome has gained attention and is increasingly noted to play a significant role in a number of disorders including CKD. Patients with CKD can be characterized with lower bacterial richness and diversity. Like the gut, human skin has its own microbiome. Recent study showed that CKD patients with pruritus had a different bacterial community comparing to those without pruritus indicating that altered skin microbiome associated with pruritus in patients with CKD and also with accumulation of uremic toxins in skin. So, the skin microbiome plays a potential role in regulating the skin symptoms in CKD patients. Therefore, these findings might be useful for making probiotics supplements to relieve patient's skin symptoms or renal damage. Indoxyl sulfate (IS) is one of the most potent protein bound uremic toxins derived from the gut microbes. IS is generated by bacterial metabolism of trptophan to indole. The serum IS was significantly elevated in patients with CKD associated pruritus. Moreover, High serum IS concentration has a strong relationship with pruritus severity and a negative impact on quality of life. Therefore, IS may represent a potential therapeutic target to reduce the pruritus severity. To decrease serum IS levels either decrease IS production by using probiotic supplementation or decrease IS intestinal absorption by addition of activated charcoal as an adsorbent agent has been evaluated in uremic patients. Probiotics are defined as live microorganisms that consumed in adequate amounts; confer a health effect on the host. Probiotics supplement regulating the immune system and improving the skin barrier. Probiotics work by competing with pathogenic organisms for nutrients, which prevent the growth of harmful bacteria. So, probiotics has a key role in improving the microbiota.Several clinical trials are being carried out on the efficacy of probiotics for the treatment of many skin problems. Some trials also showed that probiotics has a role in reducing of protein bound uremic toxin such indoxyl sulfate (IS).We hope that this study forms a contribution to promoting probiotics as a novel therapeutic approach for the treatment of uremic pruritus. Activated charcoal is a powerful, intestinal adsorbent within the gastrointestinal (GI) tract, effectively trapping various chemicals. These captured substances are then retained within the charcoal matrix, preventing or reducing their absorption into the blood stream. Activated charcoal has been found to effectively eliminate urea and other uremic toxin such as indoxyl sulfate due to its ability to bind with IS and expelling it through feces. It's also showed that the usage of activated charcoal resulted in decreasing pruritus severity and improving the quality of life of patients without serious side effects.

Interventions

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

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

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

1. Patients with psoriasis, atopic dermatitis or any other condition that can justify pruritus. 2. Patient undergoing dialysis. 3. Patients with known allergy to Activated charcoal or probiotics supplements. 4. Patients who are non-compliant.

Design outcomes

Primary

MeasureTime frameDescription
Change in serum Indoxyl sulfate (IS) levelFour weeksIS 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.
Change in visual Analog scale (VAS) score.Four weeksA 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 .
Change in Dermatology life quality index (DLQI)Four weeks10-Item questionnaire aiming to measure how much skin problem has affected on QOL . mesasuring DLQI at baseline and after a 4 weeks trial period .

Secondary

MeasureTime frameDescription
Evaluation of the safety of probiotics supplementation and activated charcoal in patients with uremic pruritus.Four weeksby monitor any adverse effects that may occur throughout the study period.

Contacts

Primary ContactAliaa Mohamed Ashraf
aliaa.mohamed22@pharma.asu.edu.eg01064831049

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026