| Trial ID: | L0634 |
| Source ID: | NCT06579066
|
| Associated Drug: |
Probiotic Blend Capsule
|
| Title: |
The Effect of Probiotics vs Activated Charcoal in the Management of CKD Patients Suffering From Uremic Pruritus.
|
| Acronym: |
|
| Status: |
NOT_YET_RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Chronic Kidney Disease|Uremic Pruritus
|
| Interventions: |
DRUG: Probiotic Blend Capsule|DRUG: Activated Charcoal
|
| Outcome Measures: |
Primary: Change in serum Indoxyl sulfate (IS) level, 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., Four weeks|Change in visual Analog scale (VAS) score., 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 ., Four weeks|Change in Dermatology life quality index (DLQI), 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 ., Four weeks | Secondary: Evaluation of the safety of probiotics supplementation and activated charcoal in patients with uremic pruritus., by monitor any adverse effects that may occur throughout the study period., Four weeks
|
| Sponsor/Collaborators: |
Sponsor: Ain Shams University
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
123
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2024-09
|
| Completion Date: |
2025-03
|
| Results First Posted: |
|
| Last Update Posted: |
2024-08-30
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| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT06579066
|
