NCT05604469

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2022

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

October 30, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 3, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

November 3, 2022

Status Verified

October 1, 2022

Enrollment Period

6 months

First QC Date

October 30, 2022

Last Update Submit

October 30, 2022

Conditions

Renal FailureHepatic FailurePruritus

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (4)

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

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

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

Interventions

Isolation of skin microbiotaDIAGNOSTIC_TEST

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

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)

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reham Essam

Zagazig, Al Sharqia, 2543, Egypt

RECRUITING

Related Publications (5)

  • 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.

    PMID: 15523377BACKGROUND

  • 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.

    PMID: 12432992BACKGROUND

  • 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.

    PMID: 26355256BACKGROUND

  • 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.

    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.

    PMID: 32331207BACKGROUND

MeSH Terms

Conditions

Renal InsufficiencyLiver FailurePruritus

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesHepatic InsufficiencyLiver DiseasesDigestive System DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSkin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Reham Essam, MD

CONTACT

+201097709477rereessam22@gmail.com

Reham Essam

CONTACT

rereessam22@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Month
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Dermatology

Study Record Dates

First Submitted

October 30, 2022

First Posted

November 3, 2022

Study Start

October 1, 2022

Primary Completion

April 1, 2023

Study Completion

June 1, 2023

Last Updated

November 3, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)