The Role of Skin Microbiota in Hepatic or Renal Pruritus

Sponsor
Zagazig University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05604469
Collaborator
(none)
60
1
8
7.5

Study Details

Study Description

Brief Summary

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

  • Skin microbiota may share in the pathogenesis of pruritus.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Isolation of skin microbiota

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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Role of Skin Microbiota in Patients With Hepatic or Renal Pruritus
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Group A (liver faluire patients with pruritus)

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

Diagnostic Test: Isolation of skin microbiota
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)

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

Group C (renal faluire patients with pruritus)

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

Group D (renal faluire patients without pruritus)

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

Outcome Measures

Primary Outcome Measures

  1. To evaluate the possible change of skin microbiota in patients with renal or hepatic pruritus [8 weeks]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Reham Essam Zagazig Al Sharqia Egypt 2543

Sponsors and Collaborators

  • Zagazig University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Reham Essam, Lecturer of Dermatology, Zagazig University
ClinicalTrials.gov Identifier:
NCT05604469
Other Study ID Numbers:
  • 9802-11-10-2022
First Posted:
Nov 3, 2022
Last Update Posted:
Nov 3, 2022
Last Verified:
Oct 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 3, 2022