Ignite Creation Date:
2024-10-25 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579066
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-27
Brief Title:
The Effect of Probiotics vs Activated Charcoal in the Management of CKD Patients Suffering From Uremic Pruritus
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The Effect of Probiotics Versus Activated Charcoal in the Management of Chronic Kidney Disease Patients Suffering From Uremic Pruritus
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 dataThe following data will be collected from the patient records including age sex weight height
History Taking Including patients medical history past surgical history family medical history and medications the patient is taking or may have recently stopped taking
A patients medical history may also include information about allergies etiology of uremic pruritus
Laboratory examinationsThe 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 ScoreVAS
2 measure Dermatology life quality index DLQI
Patient data collection
Demographic dataThe following data will be collected from the patient records including age sex weight height
History Taking Including patients medical history past surgical history family medical history and medications the patient is taking or may have recently stopped taking
A patients medical history may also include information about allergies etiology of uremic pruritus
Laboratory examinationsThe 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 ScoreVAS
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 its 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 patients 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 microbiotaSeveral 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 ISWe 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 Its 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
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 patients 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 microbiotaSeveral 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 ISWe 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 Its 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None