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临床试验/NCT06579066
NCT06579066尚未招募2 期

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

Ain Shams University0 个研究点目标入组 123 人开始时间: 2024年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
123
主要终点
Change in serum Indoxyl sulfate (IS) level

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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.

研究组 & 干预措施

probiotics

Experimental

Patients will administer Linex ® capsule orally along with the standard care of therapy for duration of 4 weeks.

Dose: Capsule once daily

干预措施: Probiotic Blend Capsule (Drug)

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.

干预措施: Activated Charcoal (Drug)

结局指标

主要结局

Change in serum Indoxyl sulfate (IS) level

时间窗: 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.

Change in visual Analog scale (VAS) score.

时间窗: 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 .

Change in Dermatology life quality index (DLQI)

时间窗: 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 .

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aliaa Mohamed Ashraf Mohamed HaGr

Dr Aliaa Mohamed

Ain Shams University

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