The Role of Skin Microbiota in Hepatic or Renal Pruritus

NCT ID: NCT05604469

Last Updated: 2022-11-03

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-06-01

Brief Summary

• 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.

Conditions

Renal Failure; Hepatic Failure; Pruritus

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A (liver faluire patients with pruritus)

Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury)

Isolation of skin microbiota

Intervention Type: DIAGNOSTIC_TEST

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

Group B (liver faluire patients without pruritus)

Patients with hepatic illness (autoimmune liver diseases, chronic viral hepatitis, and drug-induced liver injury)

Isolation of skin microbiota

Intervention Type: DIAGNOSTIC_TEST

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

Group C (renal faluire patients with pruritus)

Isolation of skin microbiota

Intervention Type: DIAGNOSTIC_TEST

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

Group D (renal faluire patients without pruritus)

Isolation of skin microbiota

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

Isolation of skin microbiota

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zagazig University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Reham Essam

Lecturer of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Reham Essam

Zagazig, Al Sharqia, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Reham Essam, MD

Role: CONTACT

rereessam22@gmail.com

+201097709477

Reham Essam

Role: CONTACT

rereessam22@gmail.com

Facility Contacts

Reham Essam

Role: primary

rereessam22@gmail.com

01097709477

References

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.

Reference Type: BACKGROUND

PMID: 15523377 (View on PubMed)

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. doi: 10.1111/j.1346-8138.2002.tb00191.x.

Reference Type: BACKGROUND

PMID: 12432992 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26355256 (View on PubMed)

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.

Reference Type: BACKGROUND

Kim 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.

Reference Type: BACKGROUND

PMID: 32331207 (View on PubMed)

Other Identifiers

9802-11-10-2022

Identifier Type: -

Identifier Source: org_study_id