Probiotic Blend Capsule
DrugPatients will administer (probiotics) Linex® one capsule daily orally along with the standard care of therapy for duration of 4 weeks.
Other names: linex®
NCT Number: NCT06579066
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).
Trial opening soon.
Get Notified18 year–75 year
All sexes
Interventional
Phase 2
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Patients will administer (probiotics) Linex® one capsule daily orally along with the standard care of therapy for duration of 4 weeks.
Other names: linex®
Patients will administer (activated charcoal) Charclone® 1000MG Tablet three times daily orally along with the standard care of therapy for duration of 4 weeks.
Other names: Charclone®
Time frame: Four weeks
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.
Time frame: Four weeks
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 .
Time frame: Four weeks
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 .
Time frame: Four weeks
by monitor any adverse effects that may occur throughout the study period.
Contact information is provided by the study sponsor or research team.
Ain Shams University
Other
The Effect of Probiotics Versus Activated Charcoal in the Management of Chronic Kidney Disease Patients Suffering From Uremic Pruritus.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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