Chronic Kidney DiseasePhase 2NCT06579066
The Effect of Probiotics vs Activated Charcoal in the Management of CKD Patients Suffering From Uremic Pruritus.
A Phase 2 study testing Probiotic Blend Capsule and Activated Charcoal in people with Chronic Kidney Disease and Uremic Pruritus, run by Ain Shams University.
Trial 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 data:The following data will be collected from the patient records; including age, sex, weight, height. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease, Uremic Pruritus
- What is being tested?
- Probiotic Blend Capsule and Activated Charcoal
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Mar 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult Patients with uremic pruritus aged from 18 years and older will be enrolled in the study.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Probiotics Versus Activated Charcoal in the Management of Chronic Kidney Disease Patients Suffering From Uremic Pruritus.
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
Read more
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)
- Serum levels of indoxyl sulfate (IS)
- Kidney Function tests: BUN, Creatinine
- Electrolytes test: sodium, potassium, chloride ,ionized calcium, phosphorus
Dermatological examination: Base on
- measure Visual Analoge Scale Score(VAS).
- measure Dermatology life quality index (DLQI).
Read the 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 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.
- Conditions
- Chronic Kidney Disease, Uremic Pruritus
- Being tested
- Probiotic Blend Capsule, Activated Charcoal
- Keywords
- Probiotics, Activated Charcoal, uremic pruritus
- Medical subject headings
- Renal Insufficiency, Chronic, Anthrax
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic Blend CapsuleDrug
Also called linex®
Patients will administer (probiotics) Linex® one capsule daily orally along with the standard care of therapy for duration of 4 weeks.
Activated CharcoalDrug
Also called Charclone®
Patients will administer (activated charcoal) Charclone® 1000MG Tablet three times daily orally along with the standard care of therapy for duration of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| probiotics | Experimental | Patients will administer Linex ® capsule orally along with the standard care of therapy for duration of 4 weeks.
Dose: Capsule once daily Receives: Drug: Probiotic Blend Capsule |
| 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. Receives: Drug: Activated Charcoal |
| Control | No intervention | Patients will administer standard care of therapy alone Telfast®120mg tablet for duration of 4 weeks.. Dose: Tablet once daily |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 .
Measured: 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 .
Measured: Four weeks
Secondary outcomes (1)
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.
Measured: Four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One hundred twenty three patients who will fit the inclusion criteria will be randomly divided into 3 groups: Group 1 (Probiotics group): 41 Patients will administer Linex®(one capsule daily) orally along with the standard care of therapy for duration of 4 weeks. Group 2 (activated charcoal): 41 Patients will administer Charclone® 1000MG Tab (Tablet three times daily) orally along with the standard care of therapy for duration of 4 weeks. Patients will take activated charcoal dose at least 2 hours before taking other drugs. Group 3 (Control group) : 41 Patients will administer standard care of therapy alone (fexofenadine) TELFAST®120mg tablet once daily
- Masking
- None (open label)
- Enrolment
- 123 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliaa Mohamed Ashraf Mohamed HaGr, Ain Shams University
- Investigators
- Aliaa Mohamed, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06579066
- Sponsor's protocol ID
- Uremic Pruitus
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 30 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 38156627Kim 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.
PubMed 32736531Szanto 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.
PubMed 31386766
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics Versus Activated Charcoal in the Management of Chronic Kidney Disease Patients Suffering From Uremic Pruritus.
- ClinicalTrials.gov ID
- NCT06579066
- Acronym / sponsor ID
- Uremic Pruitus
- Conditions
- Chronic Kidney Disease, Uremic Pruritus
- Keywords
- Probiotics, Activated Charcoal, uremic pruritus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 123 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 30 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- Serum levels of indoxyl sulfate (IS)
- Kidney Function tests: BUN, Creatinine
- Electrolytes test: sodium, potassium, chloride ,ionized calcium, phosphorus
Dermatological examination: Base on
- measure Visual Analoge Scale Score(VAS).
- 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- One hundred twenty three patients who will fit the inclusion criteria will be randomly divided into 3 groups: Group 1 (Probiotics group): 41 Patients will administer Linex®(one capsule daily) orally along with the standard care of therapy for duration of 4 weeks. Group 2 (activated charcoal): 41 Patients will administer Charclone® 1000MG Tab (Tablet three times daily) orally along with the standard care of therapy for duration of 4 weeks. Patients will take activated charcoal dose at least 2 hours before taking other drugs. Group 3 (Control group) : 41 Patients will administer standard care of therapy alone (fexofenadine) TELFAST®120mg tablet once daily
| Arm | Type | Receives |
|---|---|---|
| probiotics | Experimental | Drug: Probiotic Blend CapsulePatients will administer Linex ® capsule orally along with the standard care of therapy for duration of 4 weeks. Dose: Capsule once daily |
| activated charcoal | Experimental | Drug: Activated CharcoalPatients will administer Charclone® 1000mg tab orally along with the standard care of therapy for duration of 4 weeks. Dose: Tablet three times daily. |
| Control | No intervention | –Patients will administer standard care of therapy alone Telfast®120mg tablet for duration of 4 weeks.. Dose: Tablet once daily |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult Patients with uremic pruritus aged from 18 years and older will be enrolled in the study.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Blend CapsuleAlso: linex®Patients will administer (probiotics) Linex® one capsule daily orally along with the standard care of therapy for duration of 4 weeks. | Drug | probiotics |
| Activated CharcoalAlso: Charclone®Patients will administer (activated charcoal) Charclone® 1000MG Tablet three times daily orally along with the standard care of therapy for duration of 4 weeks. | Drug | activated charcoal |
Primary outcome
Change in serum Indoxyl sulfate (IS) level
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.
Change in visual Analog scale (VAS) score.
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 .
Change in Dermatology life quality index (DLQI)
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 .
1 secondary outcome
Evaluation of the safety of probiotics supplementation and activated charcoal in patients with uremic pruritus.
Time frame: Four weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2024.
- Background: PubMed 38156627Akl 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.
- Background: PubMed 32736531Kim 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.
- Background: PubMed 31386766Szanto 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliaa Mohamed principal investigator
Ain Shams University
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic Blend Capsule and Activated Charcoal in people with Chronic Kidney Disease and Uremic Pruritus, run by Ain Shams University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aliaa Mohamed Ashraf (01064831049, aliaa.mohamed22@pharma.asu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in serum Indoxyl sulfate (IS) level (time frame: Four weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06579066, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2024.