Renal FailureNCT05604469
The Role of Skin Microbiota in Hepatic or Renal Pruritus
An observational study of Renal Failure and Hepatic Failure, run by Zagazig University at 1 site in Egypt.
Trial summary
Various neurotransmitters may share in the pathogenesis of hepatic and renal itching. Skin microbiota may share in the pathogenesis of pruritus. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Renal Failure, Hepatic Failure, Pruritus
- What is being tested?
- Isolation of skin microbiota
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2022to 1 Jun 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients of both sexes. Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) or Patients with renal failure Willing to sign an informed consent.
Who may be able to join
- Patients of both sexes. Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) or Patients with renal failure Willing to sign an informed consent.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Reham Essam contact
Egypt1 site, 1 recruiting
- Recruiting
Reham Essam
Zagazig, Al Sharqia, 2543
Reham Essam, 01097709477, rereessam22@gmail.com
About this study
Official title: The Role of Skin Microbiota in Patients With Hepatic or Renal Pruritus
- Various neurotransmitters may share in the pathogenesis of hepatic and renal itching.
- Skin microbiota may share in the pathogenesis of pruritus.
Read the detailed description
Uremic pruritus (UP) is a frequent phenomenon and it is regarded as one of the most bothersome symptoms in patients with chronic renal disease. The prevalence of UP is still high and reported in around 40% to 50%. UP has an important impact on patients' quality of life and sleep, depression, and increased mortality. The pathogenesis of UP remains blurry, although many different factors have been indicated in the etiology of this symptom, including increased systemic inflammation, abnormal serum parathyroid hormone, calcium, and phosphorus levels, an imbalance in opiate receptors, a neuropathic process, or even skin dryness. This is why until now there is no specific treatment for patients with UP and many of the available therapeutic modalities are not satisfactory Pruritus in liver diseases can often be a debilitating symptom causing significant impairment in quality of life. Not all patients with liver disease develop pruritus and its prevalence varies depending on the underlying cause of liver disease. It is more common in conditions characterized by bile duct inflammatory destruction than in those characterized by hepatocellular injury.
Cutaneous microbiota delivers a diverse and far-reaching influence on our physiology by calling upon the host nervous system. Bacteria make metabolites, toxins, and structural components that are recognized by peripheral and central neurons via matching receptors. Microbiota also indirectly affects neural function by causing endocrine (i.e., keratinocytes) and immune cells to transmit signals (i.e., cytokines, proteases). Itch is a prototypic sensory neural function, and the microbiota propels the itch-scratch cycle.
- Conditions
- Renal Failure, Hepatic Failure, Pruritus
- Being tested
- Isolation of skin microbiota
- Medical subject headings
- Renal Insufficiency, Liver Failure, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isolation of skin microbiotaDiagnostic test
Isolation of skin microbiota including, Staphylococcus epidermidis, Propionibacterium acnes, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes and Candida.
| Study group | Role | What they receive |
|---|---|---|
| Group A (liver faluire patients with pruritus) | Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) Receives: Diagnostic Test: Isolation of skin microbiota | |
| Group B (liver faluire patients without pruritus) | Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) Receives: Diagnostic Test: Isolation of skin microbiota | |
| Group C (renal faluire patients with pruritus) | Not described Receives: Diagnostic Test: Isolation of skin microbiota | |
| Group D (renal faluire patients without pruritus) | Not described Receives: Diagnostic Test: Isolation of skin microbiota |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the possible change of skin microbiota in patients with renal or hepatic pruritus
Isolation of skin microbiota including, Staphylococcus epidermidis, Propionibacterium acnes, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes and Candida.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2022
- Study start1 Oct 2022
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Renal FailureStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Reham Essam, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05604469
- Sponsor's protocol ID
- 9802-11-10-2022
- Status last verified
- Oct 2022
- First submitted
- 30 Oct 2022
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Szepietowski JC, Salomon J. Uremic pruritus: still an important clinical problem. J Am Acad Dermatol. 2004 Nov;51(5):842-3. doi: 10.1016/j.jaad.2004.04.003. No abstract available.
PubMed 15523377Szepietowski JC, Sikora M, Kusztal M, Salomon J, Magott M, Szepietowski T. Uremic pruritus: a clinical study of maintenance hemodialysis patients. J Dermatol. 2002 Oct;29(10):621-7. doi: 10.1111/j.1346-8138.2002.tb00191.x.
PubMed 12432992Combs SA, Teixeira JP, Germain MJ. Pruritus in Kidney Disease. Semin Nephrol. 2015 Jul;35(4):383-91. doi: 10.1016/j.semnephrol.2015.06.009.
PubMed 26355256Carstens E, Akiyama T, editors. Itch: Mechanisms and Treatment. Boca Raton (FL): CRC Press/Taylor & Francis; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK200931/
PubMed 24830003Kim HS, Yosipovitch G. The Skin Microbiota and Itch: Is There a Link? J Clin Med. 2020 Apr 22;9(4):1190. doi: 10.3390/jcm9041190.
PubMed 32331207
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Skin Microbiota in Patients With Hepatic or Renal Pruritus
- ClinicalTrials.gov ID
- NCT05604469
- Acronym / sponsor ID
- 9802-11-10-2022
- Conditions
- Renal Failure, Hepatic Failure, Pruritus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 3 Nov 2022 (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.
- Various neurotransmitters may share in the pathogenesis of hepatic and renal itching.
- Skin microbiota may share in the pathogenesis of pruritus.
Detailed description
Uremic pruritus (UP) is a frequent phenomenon and it is regarded as one of the most bothersome symptoms in patients with chronic renal disease. The prevalence of UP is still high and reported in around 40% to 50%. UP has an important impact on patients' quality of life and sleep, depression, and increased mortality. The pathogenesis of UP remains blurry, although many different factors have been indicated in the etiology of this symptom, including increased systemic inflammation, abnormal serum parathyroid hormone, calcium, and phosphorus levels, an imbalance in opiate receptors, a neuropathic process, or even skin dryness. This is why until now there is no specific treatment for patients with UP and many of the available therapeutic modalities are not satisfactory Pruritus in liver diseases can often be a debilitating symptom causing significant impairment in quality of life. Not all patients with liver disease develop pruritus and its prevalence varies depending on the underlying cause of liver disease. It is more common in conditions characterized by bile duct inflammatory destruction than in those characterized by hepatocellular injury.
Cutaneous microbiota delivers a diverse and far-reaching influence on our physiology by calling upon the host nervous system. Bacteria make metabolites, toxins, and structural components that are recognized by peripheral and central neurons via matching receptors. Microbiota also indirectly affects neural function by causing endocrine (i.e., keratinocytes) and immune cells to transmit signals (i.e., cytokines, proteases). Itch is a prototypic sensory neural function, and the microbiota propels the itch-scratch cycle.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A (liver faluire patients with pruritus) | – | Diagnostic Test: Isolation of skin microbiotaPatients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) |
| Group B (liver faluire patients without pruritus) | – | Diagnostic Test: Isolation of skin microbiotaPatients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) |
| Group C (renal faluire patients with pruritus) | – | Diagnostic Test: Isolation of skin microbiota |
| Group D (renal faluire patients without pruritus) | – | Diagnostic Test: Isolation of skin microbiota |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of both sexes. Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) or Patients with renal failure Willing to sign an informed consent.
Key inclusion criteria (1 listed)
- Patients of both sexes. Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury) or Patients with renal failure Willing to sign an informed consent.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Isolation of skin microbiotaIsolation of skin microbiota including, Staphylococcus epidermidis, Propionibacterium acnes, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes and Candida. | Diagnostic test | Group A (liver faluire patients with pruritus), Group B (liver faluire patients without pruritus), Group C (renal faluire patients with pruritus), Group D (renal faluire patients without pruritus) |
Primary outcome
To evaluate the possible change of skin microbiota in patients with renal or hepatic pruritus
Time frame: 8 weeks
Isolation of skin microbiota including, Staphylococcus epidermidis, Propionibacterium acnes, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes and Candida.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 15523377Szepietowski JC, Salomon J. Uremic pruritus: still an important clinical problem. J Am Acad Dermatol. 2004 Nov;51(5):842-3. doi: 10.1016/j.jaad.2004.04.003. No abstract available.
- Background: PubMed 12432992Szepietowski JC, Sikora M, Kusztal M, Salomon J, Magott M, Szepietowski T. Uremic pruritus: a clinical study of maintenance hemodialysis patients. J Dermatol. 2002 Oct;29(10):621-7. doi: 10.1111/j.1346-8138.2002.tb00191.x.
- Background: PubMed 26355256Combs SA, Teixeira JP, Germain MJ. Pruritus in Kidney Disease. Semin Nephrol. 2015 Jul;35(4):383-91. doi: 10.1016/j.semnephrol.2015.06.009.
- Background: PubMed 24830003Carstens E, Akiyama T, editors. Itch: Mechanisms and Treatment. Boca Raton (FL): CRC Press/Taylor & Francis; 2014. Available from http://www.ncbi.nlm.nih.gov/books/NBK200931/
- Background: PubMed 32331207Kim HS, Yosipovitch G. The Skin Microbiota and Itch: Is There a Link? J Clin Med. 2020 Apr 22;9(4):1190. doi: 10.3390/jcm9041190.
- 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.
Reham Essam contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Failure and Hepatic Failure, run by Zagazig University at 1 site in Egypt.
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 0 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 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 Reham Essam, MD (+201097709477, rereessam22@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the possible change of skin microbiota in patients with renal or hepatic pruritus (time frame: 8 weeks). 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 NCT05604469, which also lists 5 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 3 Nov 2022.