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Набор скоро начнётся NCT06579066

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

Фаза II С лечением Chronic Kidney Disease Uremic Pruritus

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Probiotic Blend Capsule, Activated Charcoal.
Кому может быть актуально
Состояния в реестре: Chronic Kidney Disease, Uremic Pruritus. Базовые параметры: 18 лет — 75 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

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

Обзор

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).

Подробное описание

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.

Вмешательства

  • Препарат Probiotic Blend Capsule
    Patients will administer (probiotics) Linex® one capsule daily orally along with the standard care of therapy for duration of 4 weeks.
  • Препарат Activated Charcoal
    Patients will administer (activated charcoal) Charclone® 1000MG Tablet three times daily orally along with the standard care of therapy for duration of 4 weeks.

Первичные конечные точки

  • Change in serum Indoxyl sulfate (IS) level [Срок оценки: Four weeks]
  • Change in visual Analog scale (VAS) score. [Срок оценки: Four weeks]
  • Change in Dermatology life quality index (DLQI) [Срок оценки: Four weeks]
Вторичные конечные точки (1)
  • Evaluation of the safety of probiotics supplementation and activated charcoal in patients with uremic pruritus. [Срок оценки: Four weeks]

Критерии участия

Критерии включения

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

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

  • 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
  • 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
  • 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

Идентификаторы

NCT: NCT06579066 · Uremic Pruitus

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗