The Role of Skin Microbiota in Hepatic or Renal Pruritus

Renal Failure Clinical Trial

Official title:

The Role of Skin Microbiota in Patients With Hepatic or Renal Pruritus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05604469
• Other study ID #: 9802-11-10-2022
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2022
• Source: Zagazig University
• Contact: Reham Essam, MD
• Phone: +201097709477
• Email: rereessam22[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

• Various neurotransmitters may share in the pathogenesis of hepatic and renal itching.

• Skin microbiota may share in the pathogenesis of pruritus.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Hepatic Failure
• Hepatic Insufficiency
• Liver Failure
• Pruritus
• Renal Failure

Intervention

Diagnostic Test:
• Isolation of skin microbiota
Isolation of skin microbiota including, Staphylococcus epidermidis, Propionibacterium acnes, Pseudomonas aeruginosa, Staphylococcus aureus, Streptococcus pyogenes and Candida.

Locations

Country	Name	City	State
Egypt	Reham Essam	Zagazig	Al Sharqia

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Combs 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. Review. — View Citation

Kim HS, Yosipovitch G. The Skin Microbiota and Itch: Is There a Link? J Clin Med. 2020 Apr 22;9(4). pii: E1190. doi: 10.3390/jcm9041190. Review. — View Citation

N. V. Bergasa. Frontiers in neuroscience pruritus of cholestasis. In: Carstens E, Akiyama T, editors. Itch: mechanisms and treatment. Boca Raton, FL: CRC Press/Taylor & Francis Group; 2014.

Szepietowski JC, Salomon J. Uremic pruritus: still an important clinical problem. J Am Acad Dermatol. 2004 Nov;51(5):842-3. — View Citation

Szepietowski 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks